Devices, systems, and methods for removing targeted lesions from vessels

ABSTRACT

Devices, systems, and methods for removing targeted lesions from vessels. In at least one embodiment of a device for removing a stenotic lesion from a vessel, the device comprises a sizing portion capable of measuring a luminal size parameter when at least part of the device is positioned within a lumen of a luminal organ, a typing portion, wherein at least part of the at least one typing portion is capable of physically touching a portion of the luminal organ or a structure therein, and a treatment portion capable of removing at least part of a stenotic lesion from the luminal organ.

PRIORITY

This U.S. Utility Patent Application is a continuation-in-partapplication of, and claims priority to, copending U.S. patentapplication Ser. No. 12/428,656, filed Apr. 23, 2009, which is acontinuation-in-part application of, and claims priority to, U.S. patentapplication Ser. No. 12/098,242, filed Apr. 4, 2008 now U.S. Pat. No.8,078,274, which is a continuation-in-part application of, and claimspriority to, U.S. patent application Ser. No. 11/891,981, filed Aug. 14,2007 now U.S. Pat. No. 8,114,143, which is a divisional application of,and claims priority to, U.S. patent application Ser. No. 10/782,149,filed Feb. 19, 2004, which issued as U.S. Pat. No. 7,454,244 on Nov. 18,2008, which claims priority to U.S. Provisional Patent Application Ser.No. 60/449,266, filed Feb. 21, 2003, to U.S. Provisional PatentApplication Ser. No. 60/493,145, filed Aug. 7, 2003, and to U.S.Provisional Patent Application Ser. No. 60/502,139, filed Sep. 11, 2003.The contents of each of these applications are hereby incorporated byreference in their entirety into this disclosure.

BACKGROUND

The disclosure of the present application relates generally to devices,systems, and methods for removing stenotic lesions from vessels. In atleast one embodiment, the disclosure of the present application relatesto methods for removing stenotic lesions from vessels involvingobtaining one or more luminal size parameters of blood vessels, heartvalves and other hollow visceral organs.

Coronary Heart Disease

Coronary heart disease is caused by atherosclerotic narrowing of thecoronary arteries. It is likely to produce angina pectoris, heart attackor both. Coronary heart disease caused 466,101 deaths in USA in 1997 andis the single leading cause of death in America today. Approximately, 12million people alive today have a history of heart attack, anginapectoris or both. The break down for males and females is 49% and 51%,respectively. This year, an estimated 1.1 million Americans will have anew or recurrent coronary attack, and more than 40% of the peopleexperiencing these attacks will die as a result. About 225,000 people ayear die of coronary attack without being hospitalized. These are suddendeaths caused by cardiac arrest, usually resulting from ventricularfibrillation. More than 400,000 Americans and 800,000 patientsworld-wide undergo a non-surgical coronary artery interventionalprocedure each year. Although only introduced in the 1990s, in somelaboratories intra-coronary stents are used in 90% of these patients.

Stents increase minimal coronary lumen diameter to a greater degree thanpercutaneous transluminal coronary angioplasty (PTCA) alone according tothe results of two randomized trials using the Palmaz-Schatz stent.These trials compared two initial treatment strategies: stenting aloneand PTCA with “stent backup” if needed. In the STRESS trial, there was asignificant difference in successful angiographic outcome in favor ofstenting (96.1% vs. 89.6%).

Aortic Stenosis

Aortic Stenosis (AS) is one of the major reasons for valve replacementsin adult. AS occurs when the aortic valve orifice narrows secondary tovalve degeneration. The aortic valve area is reduced to one fourth ofits normal size before it shows a hemodynamic effect. Because the areaof the normal adult valve orifice is typically 3.0 to 4.0 cm², an area0.75-1.0 cm² is usually not considered severe AS. When stenosis issevere and cardiac output is normal, the mean trans-valvular pressuregradient is generally >50 mmHg. Some patients with severe AS remainasymptomatic, whereas others with only moderate stenosis developsymptoms. Therapeutic decisions, particularly those related tocorrective surgery, are based largely on the presence or absence ofsymptoms.

The natural history of AS in the adult consists of a prolonged latentperiod in which morbidity and mortality are very low. The rate ofprogression of the stenotic lesion has been estimated in a variety ofhemodynamic studies performed largely in patients with moderate AS.Cardiac catheterization and Doppler echocardiographic studies indicatethat some patients exhibit a decrease in valve area of 0.1-0.3 cm² peryear; the average rate of change is 0.12 cm² per year. The systolicpressure gradient across the valve may increase by as much as 10 to 15mmHg per year. However, more than half of the reported patients showedlittle or no progression over a 3-9 year period. Although it appearsthat progression of AS can be more rapid in patients with degenerativecalcific disease than in those with congenital or rheumatic disease, itis not possible to predict the rate of progression in an individualpatient.

Eventually, symptoms of angina, syncope, or heart failure develop aftera long latent period, and the outlook changes dramatically. After onsetof symptoms, average survival is <2-3 years. Thus, the development ofsymptoms identifies a critical point in the natural history of AS.

Many asymptomatic patients with severe AS develop symptoms within a fewyears and require surgery. The incidence of angina, dyspnea, or syncopein asymptomatic patients with Doppler outflow velocities of 4 m/s hasbeen reported to be as high as 38% after 2 years and 79% after 3 years.Therefore, patients with severe AS require careful monitoring fordevelopment of symptoms and progressive disease.

Indications for Cardiac Catheterization

In patients with AS, the indications for cardiac catheterization andangiography are to assess the coronary circulation (to confirm theabsence of coronary artery disease) and to confirm or clarify theclinical diagnosis of AS severity. If echocardiographic data are typicalof severe isolated. AS, coronary angiography may be all that is neededbefore aortic valve replacement (AVR). Complete left- and right-heartcatheterization may be necessary to assess the hemodynamic severity ofAS if there is a discrepancy between clinical and echocardiographic dataor evidence of associated valvular or congenital disease or pulmonaryhypertension.

The pressure gradient across a stenotic valve is related to the valveorifice area and transvalvular flow through Bernoulli's principle. Thus,in the presence of depressed cardiac output, relatively low pressuregradients are frequently obtained in patients with severe AS. On theother hand, during exercise or other high-flow states, systolicgradients can be measured in minimally stenotic valves. For thesereasons, complete assessment of AS requires (1) measurement oftransvalvular flow, (2) determination of the transvalvular pressuregradient, and (3) calculation of the effective valve area. Carefulattention to detail with accurate measurements of pressure and flow isimportant, especially in patients with low cardiac output or a lowtransvalvular pressure gradient.

Problems with Current Aortic Valve Area Measurements

Patients with severe AS and low cardiac output are often present withonly modest transvalvular pressure gradients (i.e., <30 mmHg). Suchpatients can be difficult to distinguish from those with low cardiacoutput and only mild to moderate AS. In both situations, the low-flowstate and low pressure gradient contribute to a calculated effectivevalve area that can meet criteria for severe AS. The standard valve areaformula (simplified Hakki formula which is valve area=cardiacoutput/[pressure gradient]^(1/2)) is less accurate and is known tounderestimate the valve area in low-flow states; under such conditions,it should be interpreted with caution. Although valve resistance is lesssensitive to flow than valve area, resistance calculations have not beenproved to be substantially better than valve area calculations.

In patients with low gradient stenosis and what appears to be moderateto severe AS, it may be useful to determine the transvalvular pressuregradient and calculate valve area and resistance during a baseline stateand again during exercise or pharmacological (i.e., dobutamine infusion)stress. Patients who do not have true, anatomically severe stenosisexhibit an increase in the valve area during an increase in cardiacoutput. In patients with severe AS, these changes may result in acalculated valve area that is higher than the baseline calculation butthat remains in the severe range, whereas in patients without severe AS,the calculated valve area will fall outside the severe range withadministration of dobutamine and indicate that severe AS is not present.

There are many other limitations in estimating aortic valve area inpatients with aortic stenosis using echocardiography and cardiaccatheterization. Accurate measurement of the aortic valve area inpatients with aortic stenosis can be difficult in the setting of lowcardiac output or concomitant aortic or mitral regurgitations.Concomitant aortic regurgitation or low cardiac output can overestimatethe severity of aortic stenosis. Furthermore, because of the dependenceof aortic valve area calculation on cardiac output, any under oroverestimation of cardiac output will cause inaccurate measurement ofvalve area. This is particularly important in patients with tricuspidregurgitation. Falsely measured aortic valve area could causeinappropriate aortic valve surgery in patients who do not need it.

Other Visceral Organs

Visceral organs such as the gastrointestinal tract and the urinary tractserve to transport luminal contents (fluids) from one end of the organto the other end or to an absorption site. The esophagus, for example,transports swallowed material from the pharynx to the stomach. Diseasesmay affect the transport function of the organs by changing the luminalcross-sectional area, the peristalsis generated by muscle, or bychanging the tissue components. For example, strictures in the esophagusand urethra constitute a narrowing of the organ where fibrosis of thewall may occur. Strictures and narrowing can be treated with distension,much like the treatment of plaques in the coronary arteries.

As referenced in detail above, and given the prevalence of coronaryheart disease and its potential severe prognosis, the availability ofvarious devices, systems, and methods for removing stenotic lesions fromvessels in an effective fashion would be well-received by the public,including treating physicians. The disclosure of the present applicationprovides effective devices, systems, and methods useful to removestenoic lesions and overcome known problems regarding current treatmentdevices and methods and the current lack of effective devices andmethods to perform the same.

BRIEF SUMMARY

In at least one exemplary embodiment of a device for insertion within aluminal organ of the present disclosure, the device comprises anelongated body having a distal body end, and at least one directionalsensor positioned along the elongated body at or near the distal bodyend, the at least one directional sensor capable of rotation about theelongated body. In another embodiment, the elongated body is selectedfrom the group consisting of a catheter and a wire. In yet anotherembodiment, the elongated body is configured to fit within a lumen of aluminal organ.

In at least one exemplary embodiment of a device for insertion within aluminal organ of the present disclosure, the device further comprises adetector positioned along the elongated body at or near the distal bodyend, the detector capable of measuring a luminal size parameter when atleast part of the elongated body is positioned within a lumen of aluminal organ. In an additional embodiment, the detector comprises atetrapolar arrangement of electrodes. In another embodiment, thetetrapolar arrangement of electrodes comprises two detection electrodespositioned in between two excitation electrodes. In yet anotherembodiment, the at least one directional sensor is at least oneelectrode of the tetrapolar arrangement of electrodes. In an additionalembodiment, the at least one directional sensor is independent of thetetrapolar arrangement of electrodes.

In at least one exemplary embodiment of a device for insertion within aluminal organ of the present disclosure, the at least one directionalsensor is further capable of extending outward from the elongated body.In another embodiment, when at least part of the elongated body ispositioned within a lumen of a luminal organ, the at least onedirectional sensor is capable of extending outward from the elongatedbody to physically touch the luminal organ or a structure therein. In anadditional embodiment, the at least one directional sensor is capable ofobtaining a measurement from the luminal organ or the structure thereinthat the directional sensor is touching.

In at least one exemplary embodiment of a device for insertion within aluminal organ of the present disclosure, the at least one directionalsensor is an impedance sensor, and wherein the measurement is animpedance measurement. In another embodiment, when a constant voltage isapplied to the at least one directional sensor, the measurement is acurrent measurement indicative of electrical impedance of the luminalorgan or the structure therein that the directional sensor is touching.In yet another embodiment, when a constant current is applied to the atleast one directional sensor, the measurement is a voltage measurementindicative of electrical impedance of the luminal organ or the structuretherein that the directional sensor is touching. In an additionalembodiment, the at least one directional sensor is a thermistor, andwherein the measurement is a temperature measurement.

In at least one exemplary embodiment of a device for insertion within aluminal organ of the present disclosure, the device further comprises anextension apparatus coupled to the at least one directional sensor, theextension apparatus capable of extending the at least one directionalsensor from a first position to an extended second position. In anadditional embodiment, the extension apparatus is selected from thegroup consisting of a mechanical actuator, an electro-mechanicalactuator, and a steering device. In various embodiments, the devicefurther comprises a rotation apparatus coupled to a rotatable portion ofthe elongated body, the rotation apparatus capable of rotating therotatable portion. In another embodiment, the rotation apparatus isselected from the group consisting of a mechanical actuator, anelectro-mechanical actuator, and a steering device. In yet anotherembodiment, when the at least one directional sensor is positioned alongthe elongated body on the rotatable portion, the at least onedirectional sensor is capable of rotation by operation of the rotationapparatus. In an additional embodiment, the rotatable portion is capableof a full 360° rotation about the elongated body.

In at least one exemplary embodiment of a device for insertion within aluminal organ of the present disclosure, the at least one directionalsensor is positioned at about 45 degrees to about 90 degrees of acircumference of the elongated body. In another embodiment, the devicefurther comprises at least one treatment portion capable of removing atleast part of a stenotic lesion from a luminal organ. In yet anotherembodiment, the at least one treatment portion is selected from thegroup consisting of a cutting balloon, a cryoplasty device, a rotationalatherectomy device, a laser angioplasty device, a vibrating catheter, avibrating blade, and a vibrating drill. In an additional embodiment, thedevice further comprises a detector comprising a tetrapolar arrangementof electrodes positioned along the device within a balloon, wherein theelectrodes are operable to measure at least one luminal parameter withinthe balloon at one or more stages of balloon inflation.

In at least one exemplary embodiment of a device for insertion within aluminal organ of the present disclosure, the elongated body comprises acatheter having a suction/infusion port in communication with a lumen ofthe catheter, wherein the catheter is configured to facilitate one ormore fluid injections into a lumen of a luminal organ when at least partof the elongated body is positioned therein. In an additionalembodiment, the device further comprises at least one fluid deliverysource operably coupled to the lumen of the catheter, whereby one ormore fluids may be injected from the at least one fluid delivery sourcethrough the lumen of the catheter, through the suction/infusion port,and into the luminal of the luminal organ. In various embodiments, thedevice further comprises a current/voltage source in communication withone or more of the directional sensor and the tetrapolar arrangement ofelectrodes, the current/voltage source capable of supplying a constantcurrent and/or a constant voltage thereto to facilitate one or moremeasurements indicative of electrical impedance of the luminal organ ora structure therein. In another embodiment, the device further comprisesa data acquisition and processing system operably coupled to the device,the data acquisition and processing system capable of receiving the oneor more measurements from the device and calculating at least oneluminal size parameter and/or determining at least one luminal organ orstructure type based upon the one or more measurements. In anotherembodiment, the device further comprises an inflatable balloon coupledto the elongated body, the inflatable balloon capable of inflation toplace a stent positioned around the inflatable balloon within a lumen ofa luminal organ.

In at least one embodiment of a device for insertion within a luminalorgan of the present disclosure, the device comprises an elongated bodyhaving a distal body end, the elongated body configured to fit within alumen of a luminal organ, at least one directional sensor positionedalong the elongated body at or near the distal body end, the at leastone directional sensor capable of rotation about the elongated body andfurther capable of extension outward from the elongated body tophysically touch the luminal organ or a structure therein, the at leastone directional sensor operable to obtain a measurement indicative ofelectrical impedance of the luminal organ or the structure therein thatthe directional sensor is touching, at least one detector positionedalong the elongated body at or near the distal body end, the at leastone detector capable of measuring a luminal size parameter when at leastpart of the elongated body is positioned within the lumen of the luminalorgan, and at least one treatment portion capable of removing at leastpart of a stenotic lesion from the luminal organ.

In at least one embodiment of a device for removing a stenotic lesionfrom a vessel of the present disclosure, the device comprises at leastone sizing portion capable of measuring a luminal size parameter when atleast part of the device is positioned within a lumen of a luminalorgan, at least one typing portion, wherein at least part of the atleast one typing portion is capable of physically touching a portion ofthe luminal organ or a structure therein, and at least one treatmentportion capable of removing at least part of a stenotic lesion from theluminal organ. In another embodiment, the at least one sizing portioncomprises a tetrapolar arrangement of two detection electrodespositioned in between two excitation electrodes. In yet anotherembodiment, the at least one treatment portion is selected from thegroup consisting of a cutting balloon, a cryoplasty device, a rotationalatherectomy device, a laser angioplasty device, a vibrating catheter, avibrating blade, and a vibrating drill. In an additional embodiment, theat least one treatment portion comprises a balloon, and wherein the atleast one sizing portion comprises at least one pressure sensor capableof detecting at least one pressure within the balloon at one or morestages of balloon inflation.

In at least one embodiment of a device for removing a stenotic lesionfrom a vessel of the present disclosure, the device further comprises atleast one suction/infusion port in communication with at least onedevice lumen, the suction/infusion port operable to facilitate one ormore fluid injections into the lumen of the luminal organ, and at leastone fluid delivery source operably coupled to the at least device lumen,whereby one or more fluids may be injected from the at least one fluiddelivery source through the at least one device lumen, through the atleast one suction/infusion port, and into the lumen of the luminalorgan. In another embodiment, the device further comprises a currentsource in communication with the two excitation electrodes, said currentsource operable to supply current to the two excitation electrodes toenable measurement of at least one conductance value, thereby enablingcalculation of a luminal size parameter. In yet another embodiment, thedevice further comprises a data acquisition and processing systemoperably coupled to the device, the data acquisition and processingsystem operable to receive conductance data from the device to calculateat least one luminal parameter based upon said conductance data and todisplay the calculated at least one luminal parameter to facilitateoperational control of the at least one treatment portion of the device.

In at least one embodiment of a system for removing a stenotic lesion ofa vessel of the present disclosure, the system comprises a treatmentdevice, the treatment device comprising at least one treatment portioncapable of a removing at least part of a stenotic lesion from a luminalorgan, and a sizing/typing device, the sizing/typing device comprisingelectrodes for measuring a first luminal size parameter when thetyping/sizing device is positioned within a lumen of the luminal organ,and at least one directional sensor capable of physically touching aportion of the luminal organ or a structure therein to obtain a firstvessel characteristic indicative of the luminal organ or the structuretherein. In another embodiment, the treatment device comprises acatheter, and wherein the sizing/typing device comprises a wire selectedfrom the group consisting of a guide wire, a pressure wire, and a flowwire.

In at least one embodiment of a method of removing at least part of astenotic lesion within a luminal organ of the present disclosure, themethod comprises the steps of (a) positioning at least part of a devicewithin a luminal organ at a first location, (b) operating the device toobtain a first luminal size parameter and a first measurement indicativeof electrical impedance of the luminal organ or a structure therein thatat least part of the device is physically touching at the firstlocation, (c) moving at least part of the device to a second locationwithin the luminal organ, (d) operating the device to obtain a secondluminal size parameter and a second measurement indicative of electricalimpedance of the luminal organ or the structure therein that at leastpart of the device is physically touching at the second location, (e)determining whether or not a stenotic lesion is present at either thefirst location or the second location based on one or more of the firstluminal size parameter, the first measurement, the second luminal sizeparameter, and the second measurement, (f) if the stenotic lesion ispresent, moving at least part of the device having a treatment portionto a stenotic lesion location, and (g) if the stenotic lesion ispresent, operating the treatment portion of the device to remove atleast part of the stenotic lesion. In another embodiment, the methodfurther comprises the steps of (h) measuring a then-current luminal sizeparameter at the stenotic lesion location, (i) comparing thethen-current luminal size parameter to either the first luminal sizeparameter or the second luminal size parameter that is indicative of thestenotic lesion location, and (j) if the then-current luminal sizeparameter does not equal a preferred luminal size parameter, repeatingsteps (g), (h), and (i) until the then-current luminal size parameterequals or exceeds the preferred luminal size parameter.

In at least one embodiment of a method of removing at least part of astenotic lesion within a luminal organ of the present disclosure, thepreferred luminal size parameter is determined based upon the firstluminal size parameter and the second luminal size parameter. In anotherembodiment, steps (b) and (d) are performed in the presence of a salineinjection. In yet another embodiment, the step of moving at least partof the device to a second location comprises advancing or retracting atleast part of the device within the luminal organ. In at least oneembodiment, the step of moving at least part of the device to a secondlocation comprises rotating at least part of the device within theluminal organ.

In at least one embodiment of a method of removing at least part of astenotic lesion within a luminal organ of the present disclosure, thefirst luminal size parameter, the second luminal size parameter, andthen-current luminal size parameter(s) are obtained using a detectorcoupled to the device. In another embodiment, the first measurement andthe second measurement are obtained using a directional sensor coupledto the device. In yet another embodiment, the step of measuring thenthen-current luminal size parameter at the stenotic lesion locationfurther comprises measuring a then-current measurement indicative ofelectrical impedance of the luminal organ or structure therein, andwherein the step of comparing the then-current luminal size parameter toeither the first luminal size parameter or the second luminal sizeparameter further comprises comparing either the first measurement orthe second measurement to the then-current measurement. In an additionalembodiment, steps (g), (h), and (i) are repeated if the then-currentluminal size parameter does not equal a preferred luminal size parameteror if the then-current measurement is indicative of electrical impedanceof the stenotic lesion.

In at least one embodiment of a method of removing at least part of astenotic lesion within a luminal organ of the present disclosure, themethod further comprises the step of ceasing the operation of thetreatment portion of the device when the then-current luminal sizeparameter equals or exceeds the preferred luminal size parameter. Inanother embodiment, the method further comprises the steps of selectingan appropriately-sized stent, and implanting the stent into the luminalorgan.

In at least one embodiment of a method of removing at least part of astenotic lesion within a luminal organ of the present disclosure, themethod comprises the steps of positioning a device within a luminalorgan, the device comprising at least one sizing portion, at least onetyping portion, and at least one treatment portion, operating the atleast one sizing portion of the device to obtain luminal size parameterdata, operating the at least one sizing portion of the device to obtaintype data indicative of electrical impedance of the luminal organ or astructure therein, and operating the at least one treatment portion at alocation within the luminal organ at or near a stenotic lesion, wherebyoperation of the at least one treatment portion is based upon theluminal size parameter data and the type data, whereby operation of theat least one treatment portion removes at least part of the stenoticlesion. In another embodiment, the method further comprises the step ofceasing operation of the at least one treatment portion when the luminalsize parameter data indicates a preferred luminal size parameter. In yetanother embodiment, the method further comprises the step of ceasingoperation of the at least one treatment portion when the type data is nolonger indicative of electrical, impedance of a stenotic lesion. In anadditional embodiment, the steps of operating the at least one sizingportion and operating the at least one sizing portion are performed inthe presence of a saline injection.

In at least one embodiment of a method of removing at least part of astenotic lesion within a luminal organ of the present disclosure, themethod comprises the steps of (a) positioning a device within a luminalorgan, the device comprising at least one typing portion and at leastone treatment portion, (b) operating the at least one typing portion ofthe device to obtain initial type data indicative of electricalimpedance of the luminal organ or a structure therein, (c) operating theat least one treatment portion if the type data is indicative ofelectrical impedance of a stenotic lesion to remove at least part of thestenotic lesion, and (d) operating the at least one typing portion ofthe device again to obtain then-current type data indicative ofelectrical impedance of the luminal or the structure therein, and (e)repeating steps (c) and (d) until the then-current type data does notindicate the presence of the stenotic lesion.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A shows a cross-sectional view of a vessel having a stenoticlesion and an exemplary sizing device positioned therein, according toan embodiment of the present disclosure;

FIG. 1B shows the cross-sectional view of a vessel wherein the exemplarysizing device is positioned at a second location within the vessel,according to an embodiment of the present disclosure;

FIG. 1C shows a cross-sectional view of a vessel wherein an exemplarytreatment device is positioned at a second location within the vessel,according to an embodiment of the present disclosure;

FIG. 2A shows an exemplary treatment device in operation, according toan embodiment of the present disclosure;

FIG. 2B shows the exemplary sizing device is positioned at a secondlocation within the vessel obtaining a then-current luminal sizeparameter, according to an embodiment of the present disclosure;

FIG. 2C shows the exemplary treatment device of FIGS. 1C and 2A inoperation, according to an embodiment of the present disclosure;

FIG. 3A shows the exemplary sizing device of FIG. 2B, for example,positioned at a second location within the vessel obtaining anadditional then-current luminal size parameter, according to anembodiment of the present disclosure;

FIGS. 3B and 3C show a cross-sectional views of a vessel having anexemplary sizing device and an exemplary treatment device positionedtherein, according to the present disclosure;

FIG. 4A shows a cross-sectional view of a vessel having a stenoticlesion and an exemplary combination device positioned therein, accordingto the present disclosure;

FIGS. 4B, 5A, and 5C show cross-sectional views of a vessel wherein asizing portion of the exemplary combination device is positioned at asecond location within the vessel, according to the present disclosure;

FIGS. 4C and 5B show cross-sectional views of a vessel wherein atreatment portion of the exemplary combination device is positioned at asecond location within the vessel and shown in operation, according tothe present disclosure;

FIGS. 6A-6F show various embodiments of exemplary treatment portions oftreatment devices, according to the present disclosure;

FIGS. 7A, 7B, and 7C show at least a portion of exemplary embodiments ofsizing devices, according to the present disclosure;

FIG. 8 A shows an exemplary embodiment of a sizing device comprising aballoon coupled thereto, according to an embodiment of the presentdisclosure;

FIGS. 8B and 8C show exemplary embodiments of devices placing stentswithin a vessel, according to an embodiment of the present disclosure;

FIGS. 9A and 9B show exemplary embodiments of systems useful forremoving stenotic lesions from vessels, according to the presentdisclosure;

FIG. 9C shows an exemplary embodiment of a sizing device of the presentdisclosure;

FIG. 10A shows an exemplary sizing/typing device of the presentdisclosure;

FIG. 10B shows an exemplary sizing/typing device of the presentdisclosure with an electrode extended therefrom, according to anembodiment of the present disclosure;

FIG. 10C shows an exemplary sizing/typing device of the presentdisclosure with an electrode extended therefrom and rotated, accordingto an embodiment of the present disclosure;

FIGS. 11A-11C show various embodiments of sizing/typing devicesaccording to the present disclosure;

FIGS. 12A-12C show various embodiments of sizing/typing devices havingdirectional sensors thereon, according to the present disclosure;

FIGS. 13A-14C show various embodiments of wire forms of sizing/typingdevices according to the present disclosure;

FIGS. 15A-15C show various embodiments of wire forms of sizing/typingdevices having directional sensors thereon, according to the presentdisclosure;

FIGS. 16A-16C show various embodiments of sizing/typing devicescomprising treatment portions, according to the present disclosure;

FIGS. 17A-17C show various embodiments of sizing/typing devices havingdirectional sensors and treatment portions thereon, according to thepresent disclosure;

FIGS. 18A-18C show various embodiments of wire forms of sizing/typingdevices having directional sensors and treatment portions thereon,according to the present disclosure;

FIG. 19A shows an exemplary embodiment of a sizing/typing devicecomprising a balloon coupled thereto, according to an embodiment of thepresent disclosure;

FIGS. 19B and 19C show exemplary embodiments of sizing/typing devicesplacing stents within a vessel, according to the present disclosure;

FIG. 20 shows an exemplary embodiment of a system useful for removingstenotic lesions from vessels, according to the present disclosure; and

FIGS. 21, 22A, and 22B show steps of exemplary methods of using asizing/typing device of the present disclosure.

DETAILED DESCRIPTION

Reference will now be made to the embodiments illustrated in thedrawings and specific language will be used to describe the same. Itwill nevertheless be understood that no limitation of scope is intendedby the description of these embodiments.

In at least one embodiment of a method for removing a stenotic lesion ofa vessel, the method comprises the steps of measuring at least twoluminal parameters, determining a preferred luminal size parameter, andoperating a treatment device to increase at least one of the luminalparameters.

In at least one exemplary method for removing a stenotic lesion of avessel, the method comprises the steps of measuring a first luminal sizeparameter at a first location within a vessel lumen, measuring a secondluminal size parameter at a second location within the vessel lumen,determining a preferred second luminal size parameter based upon thefirst luminal size parameter and the second luminal size parameter, andpositioning a treatment device at or near the second location. In atleast one method, the method further comprises the steps of operatingthe treatment device to increase the second luminal size parameter andmeasuring a then-current luminal size parameter at the second location.After the then-current luminal size parameter at the second location ismeasured, an exemplary method for removing a stenotic lesion of a vesselcomprises the step of comparing the then-current luminal size parameterto the preferred second luminal size parameter, and if the then-currentluminal size parameter does not equal the preferred second luminal sizeparameter, an exemplary method comprises repeating the steps ofoperating the treatment device to increase the second luminal sizeparameter, measuring another then-current luminal size parameter at thesecond location, and comparing the then-current luminal size parameterto the preferred second luminal size parameter. In at least oneembodiment of such a method, the aforementioned three steps (essentiallya feedback loop) are repeated until the then-current luminal sizeparameter equals the preferred second luminal size parameter.

In various embodiments of methods of the disclosure of the presentapplication, one or more luminal size parameters are measured. In atleast one embodiment, the various luminal size parameters (the firstluminal size parameter and the second luminal size parameter, forexample) comprise luminal diameters. For example, and when performing anexemplary method of the disclosure of the present application to removea vessel plaque (an exemplary stenotic lesion), a first luminal diametermay be measured at a location within the vessel, and a second luminaldiameter may be measured at a second location within the vessel. Inanother example, the luminal size parameters may comprise luminalcross-sectional areas. In yet another example, the luminal sizeparameters may comprise one or more other luminal geometriccalculations, including, for example, a luminal circumference, each orall of which may share one or more similar calculated components (like aluminal diameter or a luminal radius, for example).

In an exemplary embodiment of a method for removing a stenotic lesion ofa vessel of the disclosure of the present application, the firstlocation comprises a location without a stenotic lesion, and the secondlocation comprises a location with a stenotic lesion. Alternatively, andin another exemplary embodiment, the first location comprises a locationwith a relatively small stenotic lesion, and the second locationcomprises a location with relatively large stenotic lesion. In eitherembodiment, or as may be with other embodiments, the luminal sizeparameters at the first and second locations may vary from one another.

For example, and as shown in FIG. 1A, a sizing device 100 may bepositioned within the lumen of a vessel 102 at a first location “A” asshown in the figure. Sizing device 100 may then operate to determine afirst luminal size parameter at location “A”, for example, as shown inFIG. 1A. As shown in the figure, the first luminal size parameter (asindicated by the dotted line extending from one vessel wall 104 toanother) may comprise, for example, a luminal diameter or luminalcross-sectional area. In this exemplary embodiment, sizing device 100comprises a sizing portion 106 located at or near the distal end 108 ofsizing device 100. In such an embodiment, sizing portion 106 of sizingdevice 100 is the portion of sizing device 100 operable to obtain one ormore luminal size parameters. In addition, and as shown in FIG. 1A,sizing portion 106 of sizing device 100 is positioned at a firstlocation within the vessel that does not have a stenotic lesion 110.

An exemplary embodiment of a sizing device 100 positioned within thelumen of a vessel 102 at a second location is shown in FIG. 1B. As shownin FIG. 1B, sizing device 100 may be introduced further within vessel102 to a second location “B” as shown, wherein the second location is alocation within vessel 102 having a stenotic lesion 110. In such anembodiment, and as shown in FIG. 1B, sizing device 100 may be operableto determine a second luminal size parameter (as indicated by the dottedline extending from sizing device 100 at second location “B”), notingthat, for example, the second luminal size parameter may be relativelysmaller than the first luminal size parameter if the second luminal sizeparameter is obtained at a portion within vessel 102 having a stenoticlesion 110. For example, sizing device 100 may obtain a first luminaldiameter at location “A” and a second luminal diameter at location “B”,and as shown in FIGS. 1A and 1B, the first luminal diameter would belarger than the second luminal diameter.

An exemplary embodiment of a method for removing a stenotic lesion of avessel of the present application may comprise the step of positioning atreatment device within a vessel at or near at least one location withinthe vessel. As shown in FIG. 1C, a treatment device 112 is shownpositioned within a lumen of a vessel 102, wherein at least onetreatment portion 114 of treatment device 112 is positioned at or near astenotic lesion 110 present within the lumen of vessel 102. Operation oftreatment portion 114 of treatment device 112 is shown in FIG. 2A, withoperation of the device indicated by the symbols above and belowtreatment portion 114. Said operation symbols are not intended to belimited to, for example, the application of electrical current—saidsymbols are intended merely to visually indicate operation of treatmentportion 114 of treatment device 112.

After operation of treatment device 112 as shown in FIG. 2A, adetermination as to the potential effectiveness of the treatment may bemade by obtaining one or more luminal size parameters at the treatmentsite. As shown in FIG. 2B, sizing device 100 is present within the lumenof vessel 102, and is operable to obtain a then-current luminal sizeparameter (as indicated by the dotted line extending from sizing device100 at second location “B”), which, as shown in the exemplary embodimentdepicted in FIG. 2B, is relatively larger than the original secondluminal size parameter. In this embodiment, a relatively largethen-current luminal size parameter as compared to the original secondluminal size parameter is indicative of at least a partially-successfulstenotic lesion removal treatment, also as indicated by the smallerstenotic lesions 110 shown in FIG. 2B. A user may compare thethen-current luminal size parameter to any number of other obtainedluminal size parameters, including, but not limited to, the firstluminal size parameter the second luminal size parameter, and apreferred second luminal size parameter, as described within exampleFIGS. 1A-2B and herein, as appropriate.

For example, and using numerical values merely as an example, if a firstluminal size parameter is a vessel diameter of 0.7 mm, and a secondluminal size parameter at a location within a vessel 102 having at leastone stenotic lesion 110 is 0.2 mm in diameter, a user mayselect/determine a preferred second luminal size parameter of 0.5 mm indiameter, for example. Such a larger preferred second luminal sizeparameter relative to the original second luminal size parameter, whenachieved based upon a stenotic lesion removal treatment, would beindicative of a partial removal of a stenotic lesion 110 from the vessel102. A user may instead decide that a preferred second luminal sizeparameter is equivalent to the first luminal size parameter, which, asdescribed in this particular example, would be indicative of total ornear-total removal of a stenotic lesion 110 from a vessel 102 at thetreatment site.

As shown in FIG. 2C, treatment device 112 is shown re-inserted into thetreatment site at or near stenotic lesion(s) 110, and is shown operatingto potentially remove additional stenotic lesion(s) 110 from thetreatment site. The scenario shown in FIG. 2C is indicative of asituation where a user has decided that the previously-measuredthen-current luminal size parameter is not equal to or within a range ofan acceptable/preferred second luminal size parameter, and that the userhas decided to continue treatment using treatment device 112 in attemptto remove additional stenotic lesion(s) 110 from the treatment site.

FIG. 3A shows at least a portion of a sizing device present within avessel after completely successful treatment to remove one or morestenotic lesions. As shown in FIG. 3A, sizing device 100 is positionedwithin the lumen of vessel 102, whereby sizing portion 106 of sizingdevice 100 is positioned at or near the original second location(indicated by “B”). Sizing device 100 is shown operating to obtain athen-current luminal size parameter, and in this particular example, andassuming that the vessel has a constant diameter throughout the portionshown in FIG. 3A, the then-current luminal size parameter would equalthe original first luminal size parameter, indicative of completeremoval of a stenotic lesion at the treatment site. In such a situation,a user may decide to cease treatment (and thus cease operation oftreatment device 112) as the then-current luminal size parameter wouldequal to, or be within, a preferred luminal size parameter, assumingsuch a preferred luminal size parameter is equal to the original firstluminal size parameter.

FIGS. 3B and 3C are indicative of situations where a user is using asizing device and a treatment device, but does not completely remove onedevice from a vessel to use the other device. For example, and as shownin FIG. 3B, sizing portion 106 of sizing device 100 is shown positionedat or near stenotic lesion(s) 110, while at least a portion of treatmentdevice 112 remains positioned within the lumen of vessel 102. Similarly,and as shown in FIG. 3C, treatment portion 114 of treatment device 112is shown positioned at or near stenotic lesion(s) 110, while at least aportion of sizing device 100 remains positioned within the lumen ofvessel 102.

In at least an additional embodiment of a device of the disclosure ofthe present application, said device comprises at least one featureindicative of a sizing device and at least one feature indicative of atreatment device. For example, and as shown in FIGS. 4A-4C, an exemplarycombination device 400 comprises a sizing portion 106 located at or nearthe distal end of combination device 400. In addition, and as shown inthe exemplary embodiments shown in FIGS. 4A-4C, an exemplary combinationdevice 400 also comprises a treatment portion 114 positioned alongcombination device. As referenced within the present application, anexemplary combination device 400 may be substantially equivalent, if notcompletely equivalent, to an exemplary sizing device 100 of the presentapplication comprising at least one treatment portion 114, andsimilarly, an exemplary combination device 400 may be substantiallyequivalent, if not completely equivalent, to an exemplary treatmentdevice 112 comprising at least one sizing portion 106.

As shown in FIG. 4A, an exemplary combination device 400 is shownpositioned within the lumen of a vessel 102, whereby sizing portion 106of combination device 400 is positioned at or near a first locationwithin vessel 102 (as indicated by “A”). Combination device 400 may thenoperate to determine a first luminal size parameter at location “A”, forexample, as shown in FIG. 4A. As shown in the figure, the first luminalsize parameter (as indicated by the dotted line extending from onevessel wall 104 to another) may comprise, for example, a luminaldiameter or luminal cross-sectional area. In this exemplary embodiment,combination device 400 comprises a sizing portion 106 located at or nearthe distal end 402 of sizing device 400. In such an embodiment, sizingportion 106 of combination device 400 is the portion of combinationdevice 400 operable to obtain one or more luminal size parameters. Inaddition, and as shown in FIG. 4A, sizing portion 106 of combinationdevice 400 is positioned at a first location within the vessel that doesnot have a stenotic lesion 110.

An exemplary embodiment of a combination device 400 positioned withinthe lumen of a blood vessel 102 at a second location is shown in FIG.4B. As shown in FIG. 4B, combination device 400 may be introducedfurther within vessel 102 to a second location “B” as shown, wherein thesecond location is a location within vessel 102 having a stenotic lesion110. In such an embodiment, and as shown in FIG. 4B, combination device400 may be operable to determine a second luminal size parameter (asindicated by the dotted line extending from combination device 400 atsecond location “B”), noting that, for example, the second luminal sizeparameter may be relatively smaller than the first luminal sizeparameter if the second luminal size parameter is obtained at a portionwithin vessel 102 having a stenotic lesion 110. For example, combinationdevice 400 may obtain a first luminal diameter at location “A” and asecond luminal diameter at location “B”, and the first luminal diameterwould be larger than the second luminal diameter.

An exemplary embodiment of a method for removing a stenotic lesion of avessel of the present application may comprise the step of positioning acombination/treatment device within a vessel at or near at least onelocation within the vessel. As shown in FIG. 4C, combination device 400is shown positioned within a lumen of a vessel 102, wherein at least onetreatment portion 114 of combination device 400 is positioned at or neara stenotic lesion 110 present within the lumen of vessel 102. Operationof treatment portion 114 of combination device 400 is also shown in FIG.4C, with operation of the device indicated by the symbols above andbelow treatment portion 114. As referenced above in connection with theoperation of an exemplary treatment device 112, said operation symbolsare not intended to be limited to, for example, the application ofelectrical current—said symbols are intended merely to visually indicateoperation of treatment portion 114 of combination device 400.

As shown in FIG. 5A, combination device 400 is re-positioned within thelumen of vessel 102, and is operable to obtain a then-current luminalsize parameter (as indicated by the dotted line extending fromcombination device 400 at second location “B”), which, as shown in theexemplary embodiment depicted in FIG. 5A, is relatively larger than theoriginal second luminal size parameter. In this embodiment, a relativelylarge then-current luminal size parameter as compared to the originalsecond luminal size parameter is indicative of at least apartially-successful treatment, also as indicated by the smallerstenotic lesions 110 shown in FIG. 5A. A user may compare thethen-current luminal size parameter to any number of other obtainedluminal size parameters, including, but not limited to, the firstluminal size parameter the second luminal size parameter, and apreferred second luminal size parameter, as described within exampleFIGS. 4A-5A and herein, as appropriate.

As shown in FIG. 5B, combination device 400 is shown re-positionedwithin vessel 102 so that treatment portion 114 is positioned at or nearstenotic lesion(s) 110, and is shown operating to potentially removeadditional stenotic lesion(s) 110 from the treatment site. The scenarioshown in FIG. 5B is indicative of a situation where a user has decidedthat the previously-measured then-current luminal size parameter is notequal to or within a range of an acceptable/preferred second luminalsize parameter, and that the user has decided to continue treatmentusing treatment portion 114 of combination device 400 in attempt toremove additional stenotic lesion(s) 110 from the treatment site.

FIG. 5C shows at least a portion of a combination device 400 presentwithin a vessel after completely successful treatment to remove one ormore stenotic lesions. As shown in FIG. 5C, combination device 400 isre-positioned within the lumen of vessel 102, whereby sizing portion 106of combination device 400 is positioned at or near the original secondlocation (indicated by “B”). Combination device 400 is shown operatingto obtain a then-current luminal size parameter, and in this particularexample, and assuming that the vessel has a constant diameter throughoutthe portion shown in FIG. 5C, the then-current luminal size parameterwould equal the original first luminal size parameter, indicative ofcomplete removal of a stenotic lesion at the treatment site. In such asituation, a user may decide to cease treatment (and thus ceaseoperation of treatment device 112) as the then-current luminal sizeparameter would equal to, or be within, a preferred luminal sizeparameter, assuming such a preferred luminal size parameter is equal tothe original first luminal size parameter.

In at least one embodiment of a treatment portion 114 of the presentapplication, treatment portion 114 comprises a treatment portionselected from the group consisting of a cutting balloon, a cryoplastydevice, a rotational atherectomy device, a laser angioplasty device, avibrating catheter, a vibrating blade, and a vibrating drill. A commonfeature shared among these various treatment portion 114 compositions isthat each one is operable to remove at least a portion of a stenoticlesion 110 from a vessel or luminal organ. As such, a number of othertreatment portion 114 compositions either known or developed in the artmay be useful in connection with the present disclosure so long as it isoperable to remove at least a portion of a stenotic lesion 110 from avessel or luminal organ. As referenced herein, the term “vessel” isintended to encompass any number of luminal organs, including bloodvessels, present within an body.

FIGS. 6A-6F show various embodiments of at least part of varioustreatment portions 114 of exemplary treatment devices 112 of the presentdisclosure. FIG. 6A shows an exemplary treatment device 112 of thepresent disclosure positioned within a vessel 102, wherein saidtreatment device 112 comprises a treatment portion 114 comprising acutting balloon 600. Cutting balloon 600, as shown in FIG. 6A, maycomprise one or more cutting portions 602, said cutting portions 602operable to physically cut a stenotic lesion 110 within a vessel 102. Inat least one embodiment, cutting balloon 600 may be inflated within thelumen of a vessel 102, whereby the inflation of cutting balloon 600allows cutting portions 602 to engage and cut a stenotic lesion 110.

Another embodiment of a treatment portion 114 of a treatment device 112of the present disclosure is shown in FIG. 6B. As shown in FIG. 6B,treatment portion 114 comprises a cryo-balloon 604 (an exemplarycryoplasty device) capable of inflation using a relatively cold gasand/or fluid such as nitrous oxide. Inflation of cryo-balloon 604 usinga cold gas and/or fluid locally reduces the temperature within a vessel102, providing potential benefits of being able to crack and/or remove astenotic lesion 110 within said vessel 602 using such a cryoplastydevice.

An additional embodiment of an exemplary treatment device 112 of thepresent application is shown in FIG. 6C. As shown in FIG. 6C, treatmentdevice 112 comprises a rotational atherectomy device 606, wherebyrotation of rotational atherectomy device 606 operates to cut a stenoticlesion 110 positioned within a vessel 102.

FIG. 6D shows an embodiment of a treatment portion 114 of a treatmentdevice 112 comprising a laser angioplasty device 608. As shown in FIG.6D, laser angioplasty device 608 may be positioned at the distal end oftreatment device 112, and is operable to emit one or more beams of light(lasers) capable of disintegrating some or all of a stenotic lesion 110.

Additional embodiments of treatment portions 114 of exemplary treatmentdevices 112 of the disclosure of the present application are shown inFIGS. 6E and 6F. As shown in FIG. 6E, treatment portion 114 comprises avibrating catheter 610 capable of vibration, for example, in thedirections shown by the arrow in the figure. Vibrating catheter 610,when in operation, may physically remove some or all of a stenoticlesion 110 impacted by vibrating catheter 610. As shown in FIG. 6E,treatment portion 114 may comprise a vibrating drill 612, wherebyvibrating drill 612 may operate similarly to vibrating catheter 610 asdescribed above, and may be further operable to drill through a stenoticlesion 110 using drill tip 614.

The exemplary embodiments of treatment devices 114 shown in FIGS. 6A-6Fand described herein are not intended to be an exhaustive list and/ordescription of treatment devices 112 of the present application, as oneor more additional treatment devices 114 known in the art may be usefulin one or more devices, systems, and/or methods of the presentapplication.

As shown in FIGS. 1A and 1B, for example, a sizing device 100 is used todetermine the various luminal size parameters. In at least oneembodiment of at least a portion of sizing device 100, and as shown inFIG. 7A, sizing device 100 may comprise an elongated body 700 having alongitudinal axis extending from a proximal end to a distal end (asindicated by the dotted line extending from “X” to “Y” as shown in FIG.5A). An exemplary sizing device 100 of the present disclosure may alsocomprise a first excitation electrode 702 and a second excitationelectrode 704 positioned along the longitudinal axis of the elongatedbody 700 at or near a distal end 706 of the elongated body 700, and mayfurther comprise a first detection electrode 708 and a second detectionelectrode 710 positioned along the longitudinal axis of the elongatedbody 700 in between the first excitation electrode 702 and the secondexcitation electrode 704. In at least one exemplary embodiment of asizing device 100, the elongated body 700 comprises a catheter having alumen extending along the longitudinal axis of the catheter.Furthermore, other sizing portions 106 not specifically disclosed hereinbut insertable within a vessel and operable to determine at least oneluminal size parameter may comprise and/or be used within an exemplarydevice, system, and/or method of the present disclosure.

In at least one embodiment, operation of sizing device 100, sizingportion 106 of sizing device 100, or a sizing portion 106 of anotherdevice and/or system of the present disclosure, including technicaloperation of one or more electrodes disclosed herein to determine one ormore luminal size parameters, is performed as disclosed within one ormore of the patents and/or patent applications incorporated by referenceherein, including, but not limited to, the disclosure of U.S. Pat. No.7,454,244. For example, and with reference to an exemplary embodiment ofa sizing portion 106 disclosed herein comprising electrodes asreferenced herein, conductance of current flow through an organ lumenand organ wall and surrounding tissue is parallel; i.e.,

$\begin{matrix}{{G\left( {z,t} \right)} = {\frac{{{CSA}\left( {z,t} \right)} \cdot C_{b}}{L} + {G_{p}\left( {z,t} \right)}}} & \lbrack\end{matrix}$where G_(p)(z,t) is the effective conductance of the structure outsidethe bodily fluid (organ wall and surrounding tissue) at a givenposition, z, along the long axis of the organ at a given time, t, andC_(b) is the electrical conductivity of the bodily fluid which for bloodgenerally depends on the temperature, hematocrit and orientation anddeformation of blood cells, and L is the distance between the detectionelectrodes of sizing portion 106. Furthermore, Equation [1a] can berearranged to solve for an exemplary luminal size parameter, namelycross sectional area CSA(t), with a correction factor, α, if theelectric field is non-homogeneous, as

$\begin{matrix}{{C\; S\;{A\left( {z,t} \right)}} = {\frac{L}{\alpha\; C_{b}}\left\lbrack {{G\left( {z,t} \right)} - {G_{p}\left( {z,t} \right)}} \right\rbrack}} & \left\lbrack {1b} \right\rbrack\end{matrix}$

where α would be equal to 1 if the field were completely homogeneous.The parallel conductance, G_(p), is an offset error that results fromcurrent leakage.

FIG. 7B shows an exemplary embodiment of a sizing device 100 comprisingboth a treatment portion 114 and a sizing portion 106. As shown in thisexemplary embodiment, sizing portion 106 of device 100 comprises a firstexcitation electrode 702 and a second excitation electrode 704positioned along elongated body 700 at or near a distal end 706 of theelongated body 700, and further comprises a first detection electrode708 and a second detection electrode 710 positioned along the elongatedbody 700 in between the first excitation electrode 702 and the secondexcitation electrode 704. In this exemplary embodiment, sizing device100, comprising both a treatment portion 114 and a sizing portion 106,may be substantially equivalent, if not completely equivalent, to anexemplary combination device 400 of the present application

An additional exemplary embodiment of a sizing device 100 of thedisclosure of the present application is shown in FIG. 7C. As shown inFIG. 7C, sizing device 100 comprises a wire having a first excitationelectrode 702, a second excitation electrode 704, a first detectionelectrode 708, and a second detection electrode 710 positioned along thewire at or near the distal end 706 of sizing device 100.

Exemplary sizing devices 100 of the disclosure of the presentapplication, as referenced herein, are operable to measure variousluminal size parameters. In at least one embodiment wherein theelongated body of the sizing device 100 or treatment device 112comprises a catheter having a lumen extending along the longitudinalaxis of the catheter, an exemplary method for removing a stenotic lesionof a vessel of the present application comprises the step of measuring afirst luminal size parameter which comprises the steps of providingelectrical current flow to the first location through the catheter,injecting a first solution of a first compound having a firstconductivity into the vessel lumen at the first location through thecatheter, and measuring a first conductance value at the first location.An exemplary method may further comprise the steps of injecting a secondsolution of a second compound having a second conductivity into thevessel lumen at the first location through the catheter, measuring asecond conductance value at the first location, and calculating a firstluminal size parameter based on the first conductance value, the secondconductance value, the first conductivity of the first solution, and thesecond conductivity of the second solution. Such a method could be usedto measure a second and/or subsequent luminal size parameter; notingthat the location of the measuring of the conductance values may varyaccordingly (for example, at a second location).

For example, and as referenced within priority U.S. Pat. No. 7,454,244incorporated by reference in its entirety herein, at any given position,z, along the long axis of organ/vessel and at any given time, t, in thecardiac cycle, G_(p), is a constant. Hence, two injections of differentconcentrations and/or conductivities of an NaCl solution give rise totwo equations:C ₁·CSA(z,t)+L·G _(p)(z,t)=L·G ₁(z,t)  [2]andC ₂·CSA(z,t)+L·G _(p)(z,t)=L·G ₂(z,t)  [3]which can be solved simultaneously for CSA and G_(p) as

$\begin{matrix}{{{C\; S\;{A\left( {z,t} \right)}} = {L\frac{\left\lbrack {{G_{2}\left( {z,t} \right)} - {G_{1}\left( {z,t} \right)}} \right\rbrack}{\left\lbrack {C_{2} - C_{1}} \right\rbrack}}}{and}} & \lbrack 4\rbrack \\{{G_{p}\left( {z,t} \right)} = \frac{\left\lbrack {{C_{2} \cdot {G_{1}\left( {z,t} \right)}} - {C_{1} \cdot {G_{2}\left( {z,t} \right)}}} \right\rbrack}{\left\lbrack {C_{2} - C_{1}} \right\rbrack}} & \lbrack 5\rbrack\end{matrix}$where subscript “1” and subscript “2” designate any two injections ofdifferent NaCl concentrations and/or conductivities. For each injectionk, C_(k) gives rise to G_(k) which is measured as the ratio of the rootmean square of the current divided by the root mean square of thevoltage. The C_(k) is typically determined through in vitro calibrationfor the various NaCl concentrations and/or conductivities. Theconcentration of NaCl used is typically on the order of 0.45 to 1.8%.The volume of NaCl solution is typically about 5 ml, but sufficient todisplace the entire local vascular blood volume momentarily. The valuesof CSA(t) and G_(p)(t) can be determined at end-diastole or end-systole(i.e., the minimum and maximum values) or the mean thereof.

In an exemplary embodiment of method for removing a stenotic lesion of avessel of the present application, a sizing device 100 useful to measurethe various luminal size parameters comprises a wire (as shown in FIG.7C), and the treatment device 112 operable to increase at least oneluminal size parameter comprises a catheter comprising at least onetreatment portion 114. In at least one embodiment, the wire comprises afirst excitation electrode 702 and a second excitation electrode 704positioned along sizing device 100, and further comprises a firstdetection electrode 708 and a second detection electrode 710 positionedalong sizing device 100 in between the first excitation electrode 702and the second excitation electrode 704.

In another exemplary embodiment of a sizing device 100, sizing device100 may comprise a guide wire, wherein such a guide wire may bepositioned at least partially within a lumen of the catheter to guidethe catheter within a vessel and to perform at least one method step ofan exemplary method of the present disclosure.

In an exemplary embodiment of a treatment device 112 of the disclosureof the present application, treatment device 112 comprises at least onetreatment portion 114 and at least one sizing portion 106. In at leastone embodiment, the treatment portion 114 of treatment device 112 isoperable to remove at least part of a stenotic lesion. In variousembodiments, an exemplary treatment portion 114 of treatment device 112(or a sizing device 100 or a combination device 400) may comprises acutting balloon, a cryoplasty device, a rotational atherectomy device, alaser angioplasty device, a vibrating catheter, a vibrating blade, and avibrating drill, exemplary embodiments of each of the same as shown inFIGS. 6A-6F and described herein.

In at least one embodiment of an exemplary sizing portion 106 of one ormore devices of the present disclosure, sizing portion 106 comprises afirst excitation electrode 702 and a second excitation electrode 704positioned along the device, and further comprises a first detectionelectrode 708 and a second detection electrode 710 positioned along thedevice in between the first excitation electrode 702 and the secondexcitation electrode 704. In another embodiment wherein an exemplarytreatment portion 114 comprises a balloon 800 (as shown, for example, inFIG. 8A, discussed below), the sizing portion 106 of an exemplary deviceof the disclosure of the present application may comprises the same orsimilar configuration of electrodes. For example, and in at least oneembodiment, first excitation electrode 702, second excitation electrode704, first detection electrode 708, and second detection electrode 710may each be positioned along a treatment device 112 within balloon 800,and wherein the then-current luminal size parameter comprises aparameter measured within balloon 800 at one or more stages of balloon800 inflation.

In at least an additional embodiment of an exemplary device of thepresent application, the device comprises an exemplary treatment portion114 comprising a balloon 800, and further comprises an exemplary sizingportion 106 comprising at least one pressure sensor 802. As shown inFIG. 8A, an exemplary sizing device 100 comprises balloon 800surrounding the various electrodes positioned along the elongated body700 of sizing device 100. In an exemplary embodiment, pressure sensor802 is operable to detect at least one pressure within balloon 800 atone or more stages of balloon 800 inflation. As shown in FIG. 8A,balloon 800 may inflate and/or deflate via inflation/deflation port 804,allowing a gas and/or a liquid to be introduced into or removed fromballoon 800 via suction/infusion tube 806.

As described herein, a user of one or more devices comprising at leastone treatment portion 114 may, at some point, decide to stop operatingtreatment portion 114. The decision to stop may be for any number ofreasons, including, but not limited to, achieving a preferred luminalsize parameter based upon operation of treatment portion 114 on astenotic lesion 110 within a vessel. In at least one embodiment of anexemplary method for removing a stenotic lesion of a vessel of thepresent disclosure, the method further comprises the step of ceasingoperation of the treatment device 112 (or the treatment portion 114 of adevice of the disclosure of the present application) when thethen-current luminal size parameter equals the preferred second luminalsize parameter. In at least one embodiment, the preferred second luminalsize parameter is equal to the first luminal size parameter. In anotherembodiment, the preferred luminal size parameter comprises a preferredsecond luminal size parameter range.

In an exemplary embodiment of a method for removing a stenotic lesion ofthe present disclosure, the step of comparing the then-current luminalsize parameter to the preferred second luminal size parameter comprisescomparing the then-current luminal size parameter to the preferredsecond luminal size parameter range. In such a situation, and instead ofa specific numerical size parameter target, the preferred luminal sizeparameter comprises a range of acceptable values. In an exemplaryembodiment, a method for removing a stenotic lesion may comprise thestep of ceasing the operation of treatment device 112 (or the treatmentportion 114 of a device of the disclosure of the present application)when the then-current luminal size parameter is within the preferredsecond luminal size parameter range.

In at least one method for removing a stenotic lesion of the disclosureof the present application, the method further comprises the steps ofselecting an appropriately-sized stent and implanting the stent into thevessel lumen. As shown in FIG. 8B, an exemplary device of the presentapplication (shown as combination device 400) comprises a balloon 800coupled thereto, and is shown in an inflated state while positioning astent 808 within the lumen of a vessel 102. In another embodiment, andas shown in FIG. 8C, combination device 400 is shown performing asimilar operation, noting that in this exemplary embodiment, combinationdevice comprises a treatment portion 114, a sizing portion 106, and aballoon 800 positioned around various electrodes.

In at least one method for removing a stenotic lesion of the disclosureof the present application, the method further comprises the steps ofobtaining at least one additional luminal size parameter between thefirst position and the second position, and constructing a lumen profilebased upon the second luminal size parameter and the at least oneadditional luminal size parameter. In such a situation, multiple luminalsize parameters may be used to construct a visual profile of changes inluminal size parameter over time and/or during treatment. In anexemplary method, multiple luminal size parameters are taken at variouslocations, allowing for the determination of a length of a stenoticlesion to be made based upon the lumen profile.

In at least one embodiment of a system for removing a stenotic lesion ofa vessel as shown in FIG. 9A, system 900 comprises a treatment device112 and a sizing device 100. As referenced herein, and as shown in FIG.9A, treatment device 112 may comprise at least one treatment portion 114operable to remove at least part of a stenotic lesion 110, and anexemplary sizing device 100 may comprise at least one sizing portion 106(including various electrodes, for example) operable to measure a firstluminal size parameter when sizing device 100 is positioned at a firstlocation, and further operable to measure a second luminal sizeparameter when sizing device 100 is positioned at a second location.

Any or all of the characteristics, features, elements, and/orlimitations of the various devices referenced herein in connection withthe above-referenced methods may apply to one or more exemplary systemsof the present application. For example, and in an exemplary system 900,treatment device 112 may comprise a catheter, and sizing device 100 maycomprises a wire selected from the group consisting of a guide wire, apressure wire, and a flow wire. Said wire, when in use, may bepositioned at least partially within a lumen of the catheter.

As shown in FIG. 9B, and in at least one embodiment of a system 900 forremoving a stenotic lesion of a vessel of the present disclosure,treatment portion 114 of treatment device 112 comprises balloon 800, andsizing portion 106 of sizing device 100 comprises at least one pressuresensor 802. In such an embodiment, pressure sensor 802 may be operableto detect at least one pressure within balloon 800 at one or more stagesof balloon inflation. In addition, and in an exemplary embodiment,pressure sensor 802 may be operable to measure a first pressure gradientand calculate at least one luminal parameter within balloon 800 based inpart upon the first pressure gradient.

In at least one embodiment of a system for removing a stenotic lesion ofa vessel, and as shown in FIG. 9B, system 900 further comprises at leastone suction/infusion port 902 in communication with at least one lumen904 of sizing device 100, said suction/infusion port 902 operable tofacilitate one or more fluid injections into a treatment site. Inanother embodiment, and as shown in FIG. 9B, system 900 may furthercomprise at least one fluid delivery source 906 operably coupled tolumen 904 of sizing device 100, whereby one or more fluids may beinjected from fluid delivery source 906 through lumen 904 of sizingdevice 100, through suction/infusion port 902, and into the treatmentsite.

In an additional exemplary embodiment, system 900 may further comprise adata acquisition and processing system 908 operably coupled to sizingdevice 100 as shown in FIG. 9B, whereby data acquisition and processingsystem 908 is operable to receive conductance data from sizing device100. In at least one embodiment, data acquisition and processing system908 is further operable to calculate at least one luminal parameterbased upon said conductance data. In at least another embodiment, dataacquisition and processing system 908 is further operable to display thecalculated at least one luminal parameter to facilitate operationalcontrol of treatment device 112. Said parameter, along with potentiallyother data and/or parameters, may be displayed on, for example, adisplay 910 operably coupled to data acquisition and processing system908 as shown in FIG. 9B.

In at least one embodiment of a system for removing a stenotic lesion ofa vessel, and as shown in FIG. 9C, an exemplary sizing device 100comprises at least one sizing portion 106. Sizing portion 106, as shownin the embodiment of sizing device 100 in FIG. 9C, may comprise a firstexcitation electrode 702, a second excitation electrode 704, a firstdetection electrode 708, and a second detection electrode 710, and mayfurther comprise a current source 912 in communication with firstexcitation electrode 702 and second excitation electrode 704. In atleast one embodiment, current source 912 is operable to supply currentto first excitation electrode 702 and second excitation electrode 704 tofacilitate measurement of at least one conductance value, therebyfacilitating calculation of a luminal size parameter.

In at least one method for removing a stenotic lesion of a vessel of thedisclosure of the present application, the method comprises the steps ofpositioning a device within a vessel lumen, the device (for example, acombination device 400 as shown in FIGS. 4A-5C) comprising at least onesizing portion 106 and at least one treatment portion 114, and operatingsizing portion 106 of combination device 400 to obtain luminal sizeparameter data. An exemplary method may further comprise the steps ofoperating treatment portion 114 at a location within the vessel lumen ator near a stenotic lesion 110, whereby operation of treatment portion114 is based upon the luminal size parameter data, and whereby operationof treatment portion 114 increases the luminal size parameter datavalue. Such a method may further comprise the step of ceasing operationof treatment portion 114 of combination device 400 when the luminal sizeparameter data indicates a preferred luminal size parameter.

In at least one embodiment of a method for removing a stenotic lesion ofa vessel of the disclosure of the present application, the luminal sizeparameter data is displayed on a display 910 (such as a computermonitor, other monitor, or LCD display, for example), and the step ofoperating treatment portion 114 is performed based upon the displayedluminal size parameter data. In an exemplary embodiment, the luminalsize perimeter data comprises a first luminal size parameter obtained ata first location within the vessel lumen, a second luminal sizeparameter obtained at a second location within the vessel lumen, and atleast one then-current luminal size parameter obtained after initialoperation of the at least one treatment portion. Said parameters may beas previously described herein regarding one or more methods of thepresent disclosure, and may comprise, for example, diameters and/orcross-sectional areas. In at least one embodiment of such a method, thepreferred luminal size parameter is determined based upon luminal sizeparameter data obtained at a location within the vessel lumen without astenotic lesion 110. In another embodiment, the preferred luminal sizeparameter is larger than luminal size parameter data obtained at alocation within the vessel lumen at or near a stenotic lesion.

In at least one embodiment of a sizing portion 106 of a combinationdevice 400 operable to facilitate performance of one or more methods ofthe present disclosure, sizing portion 106 comprises a first excitationelectrode 702 and a second excitation electrode 704 positioned alongcombination device 400 at or near a distal end 706 of combination device400, and further comprises a first detection electrode 708 and a seconddetection electrode 710 positioned along combination device 400 inbetween first excitation electrode 702 and second excitation electrode704. Such an embodiment may comprise an embodiment of a device similarto or the same as the embodiment of an exemplary sizing device 100 asshown in FIG. 7B. In addition, said combination device 400 may compriseone or more features, elements, and/or limitations of one or more otherdevices and/or systems (or portions thereof) referenced herein,including, but not limited to, an exemplary sizing device 100, anexemplary treatment device 112, and/or an exemplary system 900.

In addition to the foregoing, and in at least one embodiment of a methodfor removing a stenotic lesion of a vessel of the disclosure of thepresent application, the step of operating the at least one sizingportion 106 may comprise obtaining multiple luminal size parametervalues during the step of operating the at least one treatment portion114.

In at least one embodiment of a device for removing a stenotic lesion ofa vessel of the disclosure of the present application, the device (forexample, a combination device 400) comprises at least one sizing portion106 and at least one treatment portion 114. Sizing portion 106 and/ortreatment portion 114 may comprise one or more features, elements,and/or limitations of one or more other devices and/or systems (orportions thereof) referenced herein, including, but not limited to, anexemplary sizing device 100, an exemplary treatment device 112, and/oran exemplary system 900.

Various additional embodiments of devices of the present disclosure areshown in FIGS. 10A-10C. In at least one embodiment of at least a portionof a sizing/typing device 1000 of the present disclosure, and as shownin FIG. 10A, sizing/typing device 1000 comprises an elongated body 1002having a longitudinal axis extending from a proximal end to a distal end1004 (as indicated by the dotted line extending from “X” to “Y” as shownin FIG. 10A), whereby said sizing/typing device 1000 is configured tofit within a lumen of a luminal organ. An exemplary sizing/typing device1000 of the present disclosure comprises a first excitation electrode702 and a second excitation electrode 704 positioned along thelongitudinal axis of the elongated body 1002 at or near a distal end1004 of the elongated body 1002, and further comprises a first detectionelectrode 708 and a second detection electrode 710 positioned along thelongitudinal axis of the elongated body 1002 in between the firstexcitation electrode 702 and the second excitation electrode 704. Asshown in FIG. 10A, second excitation electrode 704 may be referred to aselectrode “A”, second detection electrode 710 may be referred to aselectrode “B”, first detection electrode 708 may be referred to aselectrode “C”, and first excitation electrode 702 may be referred to aselectrode “D”, and are shown in an exemplary tetrapolar arrangement. Inat least one exemplary embodiment of a sizing/typing device 1000, and asshown in FIGS. 10A and 10B, the elongated body 1002 comprises a catheterhaving a lumen 1006 extending along the longitudinal axis of thecatheter.

The exemplary embodiment of at least a portion of a sizing/typing device1000 shown in FIG. 10A, as well as various other embodiments ofsizing/typing devices 1000 of the present disclosure, comprise“directional electrodes” or “directional sensors,” meaning that they donot completely extend the entire circumference of sizing/typing devices1000. As shown in FIG. 10A, an exemplary embodiment of a sizing/typingdevice 1000 of the present disclosure comprises directional electrodes(702, 708, 710, and 704, for example, which may be referred to generallyherein as an exemplary detector 1010) positioned along elongated body1002 at approximately 90° around a 360° circumference of sizing/typingdevice 1000. In at least another embodiment, said electrodes (anddirectional sensors 1200 as referenced below) are positioned atapproximately 45° around a 360° circumference of sizing/typing device1000. These directional electrodes, as discussed in further detailherein, allow a user of said sizing/typing device 1000 to obtainimpedance measurements, for example, at a portion of a vessel instead ofobtaining impedance measurements indicative of an entire circumferenceof a vessel at the location of said electrodes. Such measurements, andother measurements obtainable from exemplary detectors 1010 of thepresent disclosure, may be generally referred to as various “luminalsize parameters” indicative of, for example, luminal cross-sectionalareas or luminal diameters. In addition, such directional measurementsovercome the problems associated with average measurements at onelocation within a vessel, and may identify when a vessel is notcircumferentially uniform, as parts of a vessel at a single location maybe calcified, fibrotic, contain lipids, or be “normal.”

As shown in FIG. 10A, an exemplary sizing/typing device 1000 of thepresent disclosure comprises at least one rotatable portion 1008.Rotatable portion 1008 allows at least one electrode of sizing/typingdevice 1000 to rotate around a circumference of sizing typing device1000, allowing a user to obtain directional impedance measurements, forexample, at various portions of a vessel wall. Rotation may befacilitated by a rotation apparatus 2002 (as shown in FIG. 20), whichmay be a mechanical actuator, an electro-mechanical actuator, and/or asteering device. Rotation apparatus 2002, in at least one embodiment, iscapable of rotating rotatable portion 1008 a full 360° around elongatedbody 1002 (or wire 1300 as referenced below).

In an exemplary sizing/typing device 1000 of the present disclosure, atleast one of electrodes A, B, C, and D is capable of extending outwardfrom sizing/typing device 1000. For example, and as shown in FIG. 10B,electrode C (first detection electrode 708) is not only positionedwithin rotatable portion 1008, but also is capable of extending outwardfrom sizing/typing device 1000. Such an extension, for example, allowselectrode C (or another electrode/sensor of the present disclosure thatis capable of extending outward from a first position to an extendedsecond position) to physically touch a vessel wall and/or a substancepresent within or on a vessel wall, such as a stenotic lesion or a lipidmass. Extension of C (or another electrode/sensor of the presentdisclosure, such as a directional sensor 1200 referenced herein) may befacilitated by an extension apparatus 2004 (as shown in FIG. 20), whichmay also be a mechanical actuator, an electro-mechanical actuator,and/or a steering device.

This physical touching, as described in further detail below, provides auser of a sizing/typing device 1000 with the ability to determine whatsuch an electrode is touching (vessel wall, lesion, etc.), so that adetermination can be made as to whether or not to perform any treatmentwithin the vessel at that particular location. For example, if anelectrode/sensor of sizing/typing device 1000 extends therefrom andphysically touches a vessel wall without a lesion, a user ofsizing/typing device 1000 may decide not to, for example, operate atreatment device or a treatment portion of sizing/typing device 1000 atthat particular location so not to damage the vessel wall.Alternatively, if an electrode/sensor of sizing/typing device. 1000extends therefrom and physically touches a stenotic lesion within avessel wall, a user of sizing/typing device 1000 may decide to operate atreatment device or a treatment portion of sizing/typing device 1000 atthat particular location to remove at least part of the lesion.

FIG. 10C shows an exemplary embodiment of at least a portion of asizing/typing device 1000 of the present disclosure, whereby rotatableportion 1008 has rotated from its original position shown in FIG. 10B.In at least one embodiment, rotatable portion 1008 is capable of a full360° rotation about sizing/typing device 1000.

Additional embodiments of sizing/typing devices 1000 of the presentdisclosure are shown in FIGS. 11A-11C. In at least one embodiment of atleast a portion of a sizing/typing device 1000 of the presentdisclosure, and as shown in FIG. 11A, sizing/typing device 1000comprises an elongated body 1002 having a longitudinal axis extendingfrom a proximal end to a distal end 1004 (as indicated by the dottedline extending from “X” to “Y” as shown in FIG. 10A), and electrodes A,B, C, and D as referenced above. In at least the embodiment shown inFIG. 11A, sizing/typing device 1000 comprises a rotatable portion 1008whereby each of electrodes A, B, C, and D are present thereon. In atleast another embodiment, and as shown in FIGS. 11B and 11C,sizing/typing device 1000 comprises a rotatable portion 1008 whereby theentire distal portion of sizing/typing device 1000 may rotate, notingthat in the embodiment shown in FIG. 11A, the most distal end is notpart of rotatable portion 1008. FIG. 11B shows an exemplarysizing/typing device 1000 with a rotatable portion 1008 in a firstposition, and FIG. 11C shows an exemplary sizing/typing device 1000 witha rotatable portion 1008 in a second position rotated from the firstposition.

In a situation where a user of a sizing/typing device 1000 of thepresent disclosure desires to have the least amount of rotatable matter,a sizing/typing device 1000 as shown in FIGS. 10A-10C may be preferred.If the amount of rotatable matter is not of particular concern, anynumber of embodiments of sizing/typing devices 1000 of the presentdisclosure may be useful depending on the particular application.

At least another embodiment of a sizing/typing device 1000 of thepresent disclosure is shown in FIG. 12A. As shown in FIG. 12A,sizing/typing device 1000 comprises an elongated body 1002 having alongitudinal axis extending from a proximal end to a distal end 1004 (asindicated by the dotted line extending from “X” to “Y” as shown in FIG.10A), and further comprises electrodes A, B, C, and D as referencedherein. However, in at least the exemplary embodiment shown in FIG. 12A,sizing/typing device 1000 comprises a directional sensor 1200, wherebydirectional sensor 1200 appears along elongated body 1002 within arotatable portion 1008 of elongated body 1002. In at least oneembodiment, directional sensor 1200 is capable of extending outward fromelongated body 1000 (similar to electrode C as shown in FIG. 10B), andis further capable of rotation about elongated body 1002 (similar toelectrode C as shown in FIG. 10C). In addition, and as shown in FIGS.12B and 12C, directional sensor 1200 may be positioned at various placesalong sizing/typing device 1000, such as, for example, proximal toelectrodes A, B, C, and D (as shown in FIG. 12B), or distal toelectrodes A, B, C, and D (as shown in FIG. 12C). In each embodiment,for example, directional sensor 1200 may be positioned along elongatedbody 1002 at a rotatable portion 1008 so that directional sensor 1200may rotate as referenced herein. Furthermore, more than one directionalsensor 1200 may be used in various embodiments of sizing/typing devices1000 of the present disclosure.

In various embodiments of sizing/typing devices 1000 of the presentdisclosure, directional sensor 1200 is capable of extending outward tophysically touch a luminal organ or a structure therein when anexemplary sizing/typing device 1000 is positioned within a lumen of aluminal organ. In additional embodiments, directional sensor 1200 iscapable of obtaining a measurement from the luminal organ or thestructure therein that is indicative of what directional sensor 1200 istouching. For example, if directional sensor 1200 comprises an impedancesensor, then the measurement is an impedance measurement which isindicative of what directional sensor 1200 is touching. If a constantvoltage is applied to directional sensor 1200, the measurement is acurrent measurement, and similarly, if a constant current is applied todirectional sensor 1200, the measurement is a voltage measurement. In anembodiment where directional sensor 1200 comprises a thermistor, forexample, the measurement is a temperature measurement, which itself isindicative of what directional sensor 1200 is touching within theluminal organ.

Various additional embodiments of sizing/typing devices 1000 of thepresent disclosure are shown in FIGS. 13A-13C. As shown in FIGS.13A-13C, sizing/typing device 1000 comprises a wire 1300, wherebyelectrodes A, B, C, and D are positioned directionally thereon at ornear a distal end 1004 of wire 1300. In the exemplary embodiments showntherein, electrode C may rotate about wire 1300 (at rotatable portion1008) as shown in FIG. 13C, and may extend outwardly from wire 1300 asshown in FIG. 13B. In such exemplary embodiments and other potentialembodiments, electrodes A, B, C, and D may themselves comprise wireelectrodes with electrode/sensor tips.

Additional embodiments of sizing/typing devices 1000 of the presentdisclosure are shown in FIGS. 14A-14C. As shown in FIGS. 14A-14C,sizing/typing devices 1000 comprise wires 1300, whereby rotatableportions 1008 shown therein include each of electrodes A, B, C, and D,and/or the tip of sizing devices 1000 near their respective distal ends.

FIGS. 15A-15C show additional embodiments of sizing/typing devices 1000of the present disclosure. As shown in FIGS. 15A-15C, sizing/typingdevices 1000 comprise a directional sensor 1200 within a rotatableportion 1008 of sizing/typing devices 1000 in addition to electrodes A,B, C, and D, whereby directional sensor 1200 is positioned along wire1300 within electrodes A, B, C, and D (FIG. 15A), proximal to saidelectrodes (FIG. 15B), and distal to said electrodes (FIG. 15C).

Exemplary embodiments of sizing/typing devices 1000 of the presentdisclosure having one or more treatment portions positioned thereon areshown in FIGS. 16A-16C. As shown in FIG. 16A, sizing/typing device 1000comprises an elongated body 1002 having a lumen therethrough, whereby atreatment portion 114 is positioned thereon proximal to electrodes A, B,C, and D. FIG. 16B shows an exemplary sizing/typing device 1000comprising a wire 1300 and a treatment portion 114 is positioned thereonproximal to electrodes A, B, C, and D. Treatment portions 114 ofsizing/typing devices 1000 may comprise any number of treatment portions114 referenced herein or known in the art including, but not limited to,a cutting balloon, a cryoplasty device, a rotational atherectomy device,a laser angioplasty device, a vibrating catheter, a vibrating blade, anda vibrating drill.

An additional exemplary embodiment of a sizing/typing device 1000 of thepresent disclosure having a treatment portion 114 thereon is shown inFIG. 16C. As shown in FIG. 16C, sizing/typing device 1000 comprises awire 1300 having electrodes A, B, C, and D at or near a distal end 1004of sizing/typing device 1000. In this exemplary embodiment, electrode Cis capable of rotation and extension as referenced herein, whereby therotation of electrode C allows directional impedance measurements to beobtained, and whereby the extension of electrode C from wire 1300 allowselectrode C to physically touch a vessel wall or a body within a vesselwall (such as a plaque, for example), to allow a determination of thetype of tissue/structure said electrode is touching. The exemplaryembodiment shown in FIG. 16C comprises a treatment portion 114, so thatsuch an embodiment of a sizing/typing device 1000 can perform threeseparate tasks, including sizing of a vessel, typing a vessel or vesselstructure, and treatment of a vessel to, for example, remove a stenoticlesion.

Additional exemplary embodiments of sizing/typing devices 1000 of thepresent disclosure are shown in FIGS. 17A-18C. As shown in FIGS.17A-17C, sizing/typing devices 1000 comprise an elongated body 1002, anddirectional sensor 1200 within a rotatable portion 1008 of elongatedbody 1002, and a treatment portion 114. FIG. 17A shows an embodiment ofsizing/typing device 1000 with directional sensor 1200 at a firstposition, FIG. 17B shows directional sensor 1200 in an extendedposition, and FIG. 17C shows directional sensor 1200 in an extendedposition and rotated from its original position along elongated body1002. FIGS. 18A-18C show exemplary sizing/typing devices 1000 of thepresent disclosure comprising a directional sensor 1200 within arotatable portion 1008 of a wire 1300, and further comprising anexemplary treatment portion 114 of the present disclosure. FIGS. 18A,18B, and 18C show directional sensor in an initial position, extended,and rotated, respectively.

In an exemplary embodiment of a sizing/typing device 1000 of the presentdisclosure wherein an exemplary treatment portion 114 comprises aballoon 800 (as shown, for example, in FIG. 19A, discussed below),electrodes A, B, C, and D may each be positioned along sizing/typingdevice 1000 within balloon 800, and wherein a then-current luminal sizeparameter (obtained by electrodes A, B, C, and D) comprises a parametermeasured within balloon 800 at one or more stages of balloon 800inflation. As shown in FIG. 19A, an exemplary sizing/typing device 1000comprises balloon 800 surrounding the various electrodes positionedalong the elongated body 1002 (or wire 1300 in a wire embodiment) ofsizing/typing device 1000. In an exemplary embodiment, pressure sensor802 is capable of detecting at least one pressure within balloon 800 atone or more stages of balloon 800 inflation. As shown in FIG. 19A,balloon 800 may inflate and/or deflate via inflation/deflation port 804,allowing a gas and/or a liquid to be introduced into or removed fromballoon 800 via suction/infusion tube 806.

As shown in FIG. 19B, an exemplary sizing/typing device 1000 of thepresent application comprises a balloon 800 coupled thereto, and isshown in an inflated state while positioning a stent 808 within thelumen of a vessel 102. In another embodiment, and as shown in FIG. 19C,sizing/typing device 1000 is shown performing a similar procedure,noting that in this exemplary embodiment, sizing/typing device 1000comprises a treatment portion 114, a detector 1010, and a balloon 800positioned around various electrodes (such as a set of electrodes A, B,C, and D).

An exemplary embodiment of a system of the present disclosure is shownin FIG. 20. As shown in FIG. 20, system 2000 comprises a sizing/typingdevice 1000 comprising a directional sensor 1200 coupled to a rotationapparatus 2002 and an extension apparatus 2004. Detector 1010 compriseselectrodes first excitation electrode 702, second excitation electrode704, first detection electrode 708, and second detection electrode 710,whereby a current/voltage source 902 is coupled to directional sensor1200, first excitation electrode 702, and second excitation electrode704. Sizing/typing device 1000 may further define a lumen 1006, wherebya suction/infusion port 902 is defined at or near one end ofsizing/typing device 1000, and a fluid delivery source may be coupled tosizing device 1000 at another end of said device 1000. Sizing/typingdevice 1000 of system 2000 may further comprise at least one treatmentportion 114, and may be coupled to a data acquisition and processingsystem 908. Each of the aforementioned components of device 1000 and/orsystem 2000 may function/operate as described in the present disclosure.

Steps of using an exemplary sizing/typing device 1000 of the presentdisclosure are shown in FIG. 21. As shown in FIG. 21, an exemplarymethod 2100 of using a sizing/typing device 1000 of the presentdisclosure comprises the steps of positioning at least part of asizing/typing device 1000 within a luminal organ at a first location (anexemplary positioning step 2102) and operating sizing/typing device 1000to obtain a first luminal size parameter and a first measurementindicative of electrical impedance of the luminal organ or a structuretherein that at least part of sizing/typing device 1000 is physicallytouching at the first location (an exemplary first operation step 2104).Step 2104 may be performed in the presence of a saline injection tooptimize the output readings as referenced herein.

The first measurement indicative of electrical impedance of the luminalorgan or a structure therein allows a user of sizing/typing device 1000to know what, for example, directional sensor 1200 is touching. Forexample, and in an embodiment where a constant current is applied todirectional sensor 1200 when directional sensor 1200 is touching theluminal organ or a structure therein (such as a plaque), a voltage canbe measured and a resulting impedance can be determined based on Ohm'slaw (V=I/R, where V=voltage, I=current, and R=resistance or impedance inthe case of alternating current). If instead a constant voltage isapplied, a current can be measured and a resulting impedance can bedetermined. Physically, lipid and calcium (calcifications, such asstenotic lesions) have notably different impedance characteristics thana normal vessel wall. An exemplary study has shown that, for example,the electrical conductivities at 30 Hz for muscle, blood vessels, fat,and bone marrow (similar to a hard plaque) are 0.350, 0.32, 0.024, and0.003 S/m. Similarly, a stenotic lesion and a normal vessel havedifferent temperature characteristics, and in an embodiment of asizing/typing device 1000 of the present disclosure wherein adirectional sensor comprises a thermistor (temperature sensor),physically touching a vessel or a substance therein, especially in thepresence of a saline injection to optimize the results, would providetemperature data indicative of what directional sensor 1200 isphysically touching. Therefore, by knowing the impedance, a user ofsizing/typing device knows what directional sensor 1200 is touching atthat time, which may be, for example, calcifications, lipids, fibrosis,normal tissue, plaque components, and the like. Such measurements (aswell as measurements in connection with vessel sizing as referencedherein) can be made in the presence of a saline injection, for example,to standardize the impedance measurements by eliminating the variabilityof the conductance of blood since saline has a known conductivity. Thesaline injections may also be advantageous for temperature measurements(as generally referenced herein) with a thermistor to detect thermalmaps in the presence of reduced viscous drag forces as compared toblood, which has a higher viscosity.

Method 2100 may further comprise the steps of moving at least part ofsizing/typing device 1000 to a second location within the luminal organ(an exemplary moving step 2106), operating sizing/typing device 1000 toobtain a second luminal size parameter and a second measurementindicative of electrical impedance of the luminal organ or the structuretherein that at least part of the device is physically touching at thesecond location (an exemplary second operation step 2108), anddetermining whether or not a stenotic lesion is present at either thefirst location or the second location based on one or more of the firstluminal size parameter, the first measurement, the second luminal sizeparameter, and the second measurement (an exemplary determination step2110). If a stenotic lesion is present, method 2100 may further comprisethe steps of moving at least part of sizing/typing device 1000 having atreatment portion 114 to a stenotic lesion location (another exemplarymoving step 2106), and operating treatment portion 114 of sizing/typingdevice 1000 to remove at least part of the stenotic lesion (an exemplarytreatment step 2112).

In at least one embodiment of a method 2100 of the present disclosure,and as shown in FIG. 21, method 2100 comprises the steps of measuring athen-current luminal size parameter at the stenotic lesion location (anexemplary measurement step 2114), comparing the then-current luminalsize parameter to either the first luminal size parameter or the secondluminal size parameter that is indicative of the stenotic lesionlocation (an exemplary comparison step 2116), and if the then-currentluminal size parameter does not equal a preferred luminal sizeparameter, repeating steps 2112, 2114, and 2116 until the then-currentluminal size parameter equals or exceeds the preferred luminal sizeparameter (an exemplary repeat step 2118). In an exemplary embodiment ofmethod 2100, the preferred luminal size parameter is determined basedupon the first luminal size parameter and the second luminal sizeparameter.

In various embodiments of methods 2100 of the present disclosure, thestep of moving at least part of the device to a second location (thefirst exemplary moving step 2106 referenced above) comprises advancingor retracting at least part of sizing/typing device 1000 within theluminal organ and/or comprises rotating at least part of sizing/typingdevice 1000 within the luminal organ. In at least one embodiment, thefirst luminal size parameter, the second luminal size parameter, andthen-current luminal size parameter(s) are obtained using a detector1010 coupled to sizing/typing device 1000. In an exemplary embodiment,the first measurement and the second measurement are obtained using adirectional sensor 1200 coupled to sizing/typing device 1000.

In at least one embodiment of a method 2100 of the present disclosure,exemplary measurement step 2114 further comprises measuring athen-current measurement indicative of electrical impedance of theluminal organ or structure therein, and comparison step 2116 furthercomprises comparing either the first measurement or the secondmeasurement to the then-current measurement. In an exemplary embodiment,steps 2112, 2114, and 2116 are repeated if the then-current luminal sizeparameter does not equal a preferred luminal size parameter or if thethen-current measurement is indicative of the stenotic lesion.

In various embodiments of methods 2100 of the present disclosure asshown in FIG. 21, method 2100 further comprises the step of ceasing theoperation of treatment portion 114 of sizing/typing device 1000 when thethen-current luminal size parameter equals or exceeds the preferredluminal size parameter (an exemplary treatment cessation step 2120). Inadditional embodiments, method 2100 further comprises the steps ofselecting an appropriately-sized stent (an exemplary stent selectionstep 2122), and implanting the stent into the luminal organ (anexemplary stent implantation step 2124).

In at least one exemplary method 2100 of the present disclosure, and asshown in FIG. 22A, method 2100 comprises the steps of positioning adevice within a luminal organ, the device comprising at least one sizingportion, at least one typing portion, and at least one treatment portion(another exemplary positioning step 2102), operating the at least onesizing portion of the device to obtain luminal size parameter data (anexemplary sizing step 2200), and operating the at least one typingportion of the device to obtain type data indicative of the luminalorgan or a structure therein (an exemplary typing step 2202). Method2100 may further comprise the step of operating the at least onetreatment portion at a location within the luminal organ at or near astenotic lesion, whereby operation of the at least one treatment portionis based upon the luminal size parameter data and the type data, wherebyoperation of the at least one treatment portion removes at least part ofthe stenotic lesion (another exemplary treatment step 2112).

In various embodiments and as shown in FIG. 22A, methods 2100 mayfurther comprise the step of ceasing operation of the at least onetreatment portion (i) when the luminal size parameter data indicates apreferred luminal size parameter, or (ii) when the type data is nolonger indicative of a stenotic lesion (additional exemplary treatmentcessation steps 2120).

In another exemplary method 2100 of the present disclosure, and as shownin FIG. 22B, method 2100 comprises the steps of positioning a devicewithin a luminal organ, the device comprising at least one typingportion and at least one treatment portion (an exemplary positioningstep 2102), operating the at least one typing portion of the device toobtain initial type data indicative of electrical impedance of theluminal organ or a structure therein (an exemplary typing step 2202),operating the at least one treatment portion if the type data isindicative of a stenotic lesion to remove at least part of the stenoticlesion (an exemplary treatment step 2112), and operating the at leastone typing portion of the device again to obtain then-current type dataindicative of electrical impedance of the luminal or the structuretherein (an exemplary subsequent typing step 2202). In at least oneembodiment, method 2100 further comprises repeating steps 2112 and 2202until the then-current type data does not indicate the presence of thestenotic lesion (another exemplary repeat step 2118).

While various embodiments of devices and systems for removing targetedlesions from vessels and methods for using the same have been describedin considerable detail herein, the embodiments are merely offered by wayof non-limiting examples of the disclosure described herein. It willtherefore be understood that various changes and modifications may bemade, and equivalents may be substituted for elements thereof, withoutdeparting from the scope of the disclosure. Indeed, this disclosure isnot intended to be exhaustive or to limit the scope of the disclosure.

Further, in describing representative embodiments, the disclosure mayhave presented a method and/or process as a particular sequence ofsteps. However, to the extent that the method or process does not relyon the particular order of steps set forth herein, the method or processshould not be limited to the particular sequence of steps described.Other sequences of steps may be possible. Therefore, the particularorder of the steps disclosed herein should not be construed aslimitations of the present disclosure. In addition, disclosure directedto a method and/or process should not be limited to the performance oftheir steps in the order written. Such sequences may be varied and stillremain within the scope of the present disclosure.

I claim:
 1. A device for insertion within a luminal organ, comprising:an elongated body having a distal body end, a fixed portion, and arotatable portion at or near the distal body end; at least onedirectional sensor positioned on the rotatable portion of the elongatedbody, the at least one directional sensor configured for axial rotationrelative to and distinct from the fixed portion of the elongated bodyand operable to obtain a measurement from the luminal organ or astructure therein, wherein the measurement is indicative of less than anentire circumference of the luminal organ; and at least one treatmentportion capable of removing at least part of a stenotic lesion from aluminal organ; and an extension apparatus coupled to the at least onedirectional sensor, the extension apparatus capable of moving the atleast one directional sensor radially relative a longitudinal axis ofthe elongated body between a first position and an extended secondposition.
 2. The device of claim 1, wherein the elongated body isselected from the group consisting of a catheter and a wire.
 3. Thedevice of claim 1, wherein the elongated body is configured to fitwithin a lumen of a luminal organ.
 4. The device of claim 1, furthercomprising: a detector positioned along the elongated body at or nearthe distal body end, the detector capable of measuring a luminal sizeparameter when at least part of the elongated body is positioned withina lumen of a luminal organ.
 5. The device of claim 4, wherein thedetector comprises a tetrapolar arrangement of electrodes.
 6. The deviceof claim 5, wherein the tetrapolar arrangement of electrodes comprisestwo detection electrodes positioned in between two excitationelectrodes.
 7. The device of claim 6, wherein the at least onedirectional sensor is at least one electrode of the tetrapolararrangement of electrodes.
 8. The device of claim 6, wherein the atleast one directional sensor is independent of the tetrapolararrangement of electrodes.
 9. The device of claim 5, further comprising:a current/voltage source in communication with one or more of thedirectional sensor and the tetrapolar arrangement of electrodes, thecurrent/voltage source capable of supplying a constant current and/or aconstant voltage thereto to facilitate one or more measurementsindicative of electrical impedance of the luminal organ or a structuretherein.
 10. The device of claim 9, further comprising: a dataacquisition and processing system operably coupled to the device, thedata acquisition and processing system capable of receiving the one ormore measurements from the device and calculating at least one luminalsize parameter and/or determining at least one luminal organ orstructure type based upon the one or more measurements.
 11. The deviceof claim 1, wherein the at least one directional sensor is furthercapable of-extending outward from the elongated body.
 12. The device ofclaim 11, wherein when at least part of the elongated body is positionedwithin a lumen of a luminal organ, the at least one directional sensoris capable of extending outward from the elongated body to physicallytouch the luminal organ or the structure therein.
 13. The device ofclaim 12, wherein the at least one directional sensor is capable ofobtaining the measurement from the luminal organ or the structuretherein that the directional sensor is touching.
 14. The device of claim13, wherein the at least one directional sensor is an impedance sensor,and wherein the measurement is an impedance measurement.
 15. The deviceof claim 13, wherein when a constant voltage is applied to the at leastone directional sensor, the measurement is a current measurementindicative of electrical impedance of the luminal organ or the structuretherein that the directional sensor is touching.
 16. The device of claim13, wherein when a constant current is applied to the at least onedirectional sensor, the measurement is a voltage measurement indicativeof electrical impedance of the luminal organ or the structure thereinthat the directional sensor is touching.
 17. The device of claim 13,wherein the at least one directional sensor is a thermistor, and whereinthe measurement is a temperature measurement.
 18. The device of claim 1,wherein the extension apparatus is selected from the group consisting ofa mechanical actuator, an electro-mechanical actuator, and a steeringdevice.
 19. The device of claim 1, further comprising a rotationapparatus coupled to the rotatable portion of the elongated body, therotation apparatus capable of rotating the rotatable portion.
 20. Thedevice of claim 19, wherein the rotation apparatus is selected from thegroup consisting of a mechanical actuator, an electro-mechanicalactuator, and a steering device.
 21. The device of claim 19, whereinwhen the at least one directional sensor is positioned along theelongated body on the rotatable portion, the at least one directionalsensor is capable of rotation by operation of the rotation apparatus.22. The device of claim 19, wherein the rotatable portion is capable ofa full 360° rotation about the elongated body.
 23. The device of claim1, wherein the at least one directional sensor is positioned at about 45degrees to about 90 degrees of a circumference of the elongated body.24. The device of claim 1, wherein the at least one treatment portion isselected from the group consisting of a cutting balloon, a cryoplastydevice, a rotational atherectomy device, a laser angioplasty device, avibrating catheter, a vibrating blade, and a vibrating drill.
 25. Thedevice of claim 1, further comprising: a detector comprising atetrapolar arrangement of electrodes positioned along the device withina balloon, wherein the electrodes are operable to measure at least oneluminal parameter within the balloon at one or more stages of ballooninflation.
 26. The device of claim 1, wherein the elongated bodycomprises a catheter having a suction/infusion port in communicationwith a lumen of the catheter, wherein the catheter is configured tofacilitate one or more fluid injections into a lumen of a luminal organwhen at least part of the elongated body is positioned therein.
 27. Thedevice of claim 26, further comprising: at least one fluid deliverysource operably coupled to the lumen of the catheter, whereby one ormore fluids may be injected from the at least one fluid delivery sourcethrough the lumen of the catheter, through the suction/infusion port,and into the luminal of the luminal organ.
 28. The device of claim 1,further comprising: an inflatable balloon coupled to the elongated body,the inflatable balloon capable of inflation to place a stent positionedaround the inflatable balloon within a lumen of a luminal organ.
 29. Adevice for insertion within a luminal organ, comprising: an elongatedbody having a distal body end, a fixed portion, and a rotatable portionat or near the distal body end, the elongated body configured to fitwithin a lumen of a luminal organ; at least one directional sensorpositioned on the rotatable portion of the elongated body, the at leastone directional sensor configured for axial rotation relative to anddistinct from the fixed portion of the elongated body and furthercapable of moving between a first position and an extended secondposition, the at least one directional sensor extending outward from theelongated body and toward the luminal organ or a structure therein whenin the extended second position to facilitate physically touching thesame, the at least one directional sensor operable to obtain ameasurement from the luminal organ or the structure therein, wherein themeasurement is indicative of less than an entire circumference of theluminal organ and indicative of electrical impedance of the luminalorgan or the structure therein when the directional sensor is touchingthe luminal organ or the structure therein; at least one detectorpositioned along the elongated body at or near the distal body end, theat least one detector capable of measuring a luminal size parameter whenat least part of the elongated body is positioned within the lumen ofthe luminal organ; an extension apparatus coupled to the at least onedirectional sensor, the extension apparatus capable of moving the atleast one directional sensor radially relative a longitudinal axis ofthe elongated body between a first position and an extended secondposition; and at least one treatment portion capable of removing atleast part of a stenotic lesion from the luminal organ.
 30. A device forremoving a stenotic lesion from a vessel, comprising: an elongated bodyhaving a fixed portion and a rotatable portion; at least one sizingportion comprising a directional sensor capable of measuring a luminalsize parameter when at least part of the device is positioned within alumen of a luminal organ, at least part of the at least one sizingportion positioned on the rotatable portion of the elongated body,wherein the portion of the at least one sizing portion on the rotatableportion is configured for axial rotation relative to and distinct fromthe fixed portion of the elongated body and operable to obtain ameasurement from the luminal organ or a structure therein, wherein themeasurement is indicative of less than an entire circumference of theluminal organ; at least one typing portion, wherein at least part of theat least one typing portion is capable moving to an extended positionoutward from the device and further capable of physically touching aportion of the luminal organ or a structure therein upon extension fromthe device; an extension apparatus coupled to the at least onedirectional sensor, the extension apparatus capable of moving the atleast one directional sensor radially relative a longitudinal axis ofthe elongated body between a first position and an extended secondposition; and at least one treatment portion capable of removing atleast part of a stenotic lesion from the luminal organ.
 31. The deviceof claim 30, wherein the at least one sizing portion comprises atetrapolar arrangement of two detection electrodes positioned in betweentwo excitation electrodes.
 32. The device of claim 31, furthercomprising: a current source in communication with the two excitationelectrodes, said current source operable to supply current to the twoexcitation electrodes to enable measurement of at least one conductancevalue, thereby enabling calculation of a luminal size parameter.
 33. Thedevice of claim 30, wherein the at least one treatment portion isselected from the group consisting of a cutting balloon, a cryoplastydevice, a rotational atherectomy device, a laser angioplasty device, avibrating catheter, a vibrating blade, and a vibrating drill.
 34. Thedevice of claim 30, wherein the at least one treatment portion comprisesa balloon, and wherein the at least one sizing portion comprises atleast one pressure sensor capable of detecting at least one pressurewithin the balloon at one or more stages of balloon inflation.
 35. Thedevice of claim 30, further comprising: at least one suction/infusionport in communication with at least one device lumen, thesuction/infusion port operable to facilitate one or more fluidinjections into the lumen of the luminal organ; and at least one fluiddelivery source operably coupled to the at least device lumen, wherebyone or more fluids may be injected from the at least one fluid deliverysource through the at least one device lumen, through the at least onesuction/infusion port, and into the lumen of the luminal organ.
 36. Thedevice of claim 30, further comprising: a data acquisition andprocessing system operably coupled to the device, the data acquisitionand processing system operable to receive conductance data from thedevice to calculate at least one luminal parameter based upon saidconductance data and to display the calculated at least one luminalparameter to facilitate operational control of the at least onetreatment portion of the device.
 37. A system for removing a stenoticlesion of a vessel, the system comprising: a treatment device, thetreatment device comprising at least one treatment portion capable of aremoving at least part of a stenotic lesion from a luminal organ; and asizing/typing device separate from the treatment device, thesizing/typing device comprising: an elongated body having a distal bodyend, a fixed portion, and a rotatable portion at or near the distal bodyend; electrodes positioned along the elongated body for measuring afirst luminal size parameter when the typing/sizing device is positionedwithin a lumen of the luminal organ, at least one directional sensorpositioned on the rotatable portion of the elongated body and configuredfor axial rotation relative to and distinct from the fixed portion ofthe sizing/typing device and configured to physically touch a portion ofthe luminal organ or a structure therein and operable to obtain a firstvessel characteristic indicative of the luminal organ or the structuretherein, wherein the measurement is indicative of less than an entirecircumference of the luminal organ, and an extension apparatus coupledto the at least one directional sensor, the extension apparatus capableof moving the at least one directional sensor radially relative alongitudinal axis of the elongated body between a first position and anextended second position.
 38. The system of claim 37, wherein thetreatment device comprises a catheter, and wherein the sizing/typingdevice comprises a wire selected from the group consisting of a guidewire, a pressure wire, and a flow wire.
 39. A method of removing atleast part of a stenotic lesion within a luminal organ, the methodcomprising the steps of: (a) positioning at least part of a devicewithin a luminal organ at a first location, the device comprising anelongated body having a distal body end with at least one directionalsensor positioned on a rotatable portion thereof at or near the distalbody end, the at least one directional sensor configured for axialrotation relative to and distinct from a fixed portion of the elongatedbody and operable to obtain a measurement from the luminal organ or astructure therein, wherein the measurement is indicative of less than anentire circumference of the luminal organ, and wherein the devicefurther comprises an extension apparatus coupled to the at least onedirectional sensor, the extension apparatus capable of moving the atleast one directional sensor radially relative a longitudinal axis ofthe elongated body between a first position and an extended secondposition; (b) operating the device to obtain a first luminal sizeparameter and a first measurement indicative of electrical impedance ofthe luminal organ or a structure therein that at least part of thedevice is physically touching at the first location; (c) moving at leastpart of the device to a second location within the luminal organ; (d)operating the device to obtain a second luminal size parameter and asecond measurement indicative of electrical impedance of the luminalorgan or the structure therein that at least part of the device isphysically touching at the second location; (e) determining whether ornot a stenotic lesion is present at either the first location or thesecond location based on one or more of the first luminal sizeparameter, the first measurement, the second luminal size parameter, andthe second measurement; (f) if the stenotic lesion is present, moving atleast part of the device having a treatment portion to a stenotic lesionlocation, the treatment portion capable of removing at least part of thestenotic lesion from the luminal organ; and (g) if the stenotic lesionis present, operating the treatment portion of the device to remove atleast part of the stenotic lesion.
 40. The method of claim 39, furthercomprising the steps of: (h) measuring a then-current luminal sizeparameter at the stenotic lesion location; (i) comparing thethen-current luminal size parameter to either the first luminal sizeparameter or the second luminal size parameter that is indicative of thestenotic lesion location; and (j) if the then-current luminal sizeparameter does not equal a preferred luminal size parameter, repeatingsteps (g), (h), and (i) until the then-current luminal size parameterequals or exceeds the preferred luminal size parameter.
 41. The methodof claim 40, wherein the step of measuring then then-current luminalsize parameter at the stenotic lesion location further comprisesmeasuring a then-current measurement indicative of electrical impedanceof the luminal organ or structure therein, and wherein the step ofcomparing the then-current luminal size parameter to either the firstluminal size parameter or the second luminal size parameter furthercomprises comparing either the first measurement or the secondmeasurement to the then-current measurement.
 42. The method of claim 41,wherein steps (g), (h), and (i) are repeated if the then-current luminalsize parameter does not equal a preferred luminal size parameter or ifthe then-current measurement is indicative of electrical impedance ofthe stenotic lesion.
 43. The method of claim 40, further comprising thestep of: ceasing the operation of the treatment portion of the devicewhen the then-current luminal size parameter equals or exceeds thepreferred luminal size parameter.
 44. The method of claim 40, furthercomprising the steps of: selecting an appropriately-sized stent; andimplanting the stent into the luminal organ.
 45. The method of claim 39,wherein the preferred luminal size parameter is determined based uponthe first luminal size parameter and the second luminal size parameter.46. The method of claim 39, wherein steps (b) and (d) are performed inthe presence of a saline injection.
 47. The method of claim 39, whereinthe step of moving at least part of the device to a second locationcomprises advancing or retracting at least part of the device within theluminal organ.
 48. The method of claim 39, wherein the step of moving atleast part of the device to a second location comprises rotating atleast part of the device within the luminal organ.
 49. The method ofclaim 39, wherein the first luminal size parameter, the second luminalsize parameter, and then-current luminal size parameter(s) are obtainedusing a detector coupled to the device.
 50. The method of claim 39,wherein the first measurement and the second measurement are obtainedusing the at least one directional sensor or another directional sensorcoupled to the device.
 51. A method for removing at least part of astenotic lesion from a luminal organ, the method comprising the stepsof: positioning a device within a luminal organ, the device comprisingan elongated body having a distal body end and having at least onesizing portion, at least one typing portion, and at least one treatmentportion, at least one of the at least one sizing portion and/or the atleast one typing portion at or near the distal body end and comprisingat least one directional sensor positioned on a rotatable portion of theelongated body and configured for axial rotation relative to anddistinct from a fixed portion of the elongated body and operable toobtain a measurement from the luminal organ or a structure therein,wherein the measurement is indicative of less than an entirecircumference of the luminal organ, and wherein the device furthercomprises an extension apparatus coupled to the at least one directionalsensor, the extension apparatus capable of moving the at least onedirectional sensor radially relative a longitudinal axis of theelongated body between a first position and an extended second position;operating the at least one sizing portion of the device to obtainluminal size parameter data; operating the at least one sizing portionof the device to obtain type data indicative of electrical impedance ofthe luminal organ or a structure therein; and operating the at least onetreatment portion capable of removing at least part of a stenotic lesionfrom the luminal organ at a location within the luminal organ at or nearthe stenotic lesion, whereby operation of the at least one treatmentportion is based upon the luminal size parameter data and the type data,whereby operation of the at least one treatment portion removes at leastpart of the stenotic lesion.
 52. The method of claim 51, furthercomprising the step of: ceasing operation of the at least one treatmentportion when the luminal size parameter data indicates a preferredluminal size parameter.
 53. The method of claim 51, further comprisingthe step of: ceasing operation of the at least one treatment portionwhen the type data is no longer indicative of electrical impedance of astenotic lesion.
 54. The method of claim 51, wherein the steps ofoperating the at least one sizing portion and operating the at least onesizing portion are performed in the presence of a saline injection. 55.A method of removing at least part of a stenotic lesion from a vessel,the method comprising the steps of: (a) positioning a device within aluminal organ, the device comprising an elongated body having a distalbody end and having at least one typing portion and at least onetreatment portion, the at least one typing portion at or near the distalbody end comprising at least one directional sensor positioned on arotatable portion of the elongated body and configured for axialrotation relative to and distinct from a fixed portion of the elongatedbody and operable to obtain a measurement from the luminal organ or astructure therein, wherein the measurement is indicative of less than anentire circumference of the luminal organ, and wherein the devicefurther comprises an extension apparatus coupled to the at least onedirectional sensor, the extension apparatus capable of moving the atleast one directional sensor radially relative a longitudinal axis ofthe elongated body between a first position and an extended secondposition; (b) operating the at least one typing portion of the device toobtain initial type data indicative of electrical impedance of theluminal organ or a structure therein; (c) operating the at least onetreatment portion capable of removing at least part of a stenotic lesionfrom the luminal organ if the type data is indicative of electricalimpedance of the stenotic lesion to remove at least part of the stenoticlesion; and (d) operating the at least one typing portion of the deviceagain to obtain then-current type data indicative of electricalimpedance of the luminal or the structure therein; and (e) repeatingsteps (c) and (d) until the then-current type data does not indicate thepresence of the stenotic lesion.